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Orthodontic Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref F5423-12Ref F5613-13Ref F5281-903Ref F5413-32Ref F5615-06Ref F5420-07Ref F5782O02Ref F5274-06Ref F5471-91Ref F5513-02Ref F5473-23Ref F5673-13Ref F5410-81Ref F5413-13Ref F5889O03Ref F5483-906Ref F5413-932Ref F5415-16Ref F5173-06Ref F5414-07Ref F5514-06Ref F5621-13Ref F5415-906Ref F5113-906Ref F5383-93Ref F5320-93Ref F5773O02Ref F5473-912Ref F5273-07Ref F5481-923Ref F5481-12Ref F5273-906Ref F5122-03Ref F5421-13Ref F5489-16Ref F5489-13Ref F5414-916Ref F5315-93Ref F5413-936Ref F5421-922Ref F5483-94Ref F5311-93Ref F5173-03Ref F5173-906Ref F5078-904Ref F5122-02Ref F5884O06Ref F5473-913Ref F5882O02Ref F5422-23Ref F5673-12Ref F5673-17Ref F5675-07Ref F5773O07Ref F5473-917Ref F5175-07Ref F5382-01Ref F5070-93Ref F5373-93Ref F5273-907Ref F5423-17Ref F5328-04Ref F5889O02Ref F5089-902Ref F5380-93Ref F5422-22Ref F5113-907Ref F5481-92Ref F5613-12Ref F5713O03Ref F5606-81Ref F5473-12Ref F5310-93Ref F5489-912Ref F5719O02Ref F5513-06Ref F5481-23Ref F5483-23Ref F5473-17Ref F5181-902Ref F5513-03Ref F5080-915Ref F5515-06Ref F5485-906Ref F5179-903Ref F5413-26Ref F5473-922Ref F5274-907Ref F5378-04Ref F5415-907Ref F5483-926Ref F5482-13Ref F5119-02Ref F5883O03Ref F5413-922Ref F5480-91Ref F5485-07Ref F5483-923Ref F5473-06Ref F5720O05Ref F5119-903Ref F5173-907Ref F5483-07Ref F5413-916Ref F5473-926Ref F5011-93Ref F5470-93Ref F5482-03Ref F5410-94Ref F5282-03Ref F5774O07Ref F5775O07Ref F5175-907Ref F5522-02Ref F5422-13Ref F5782O03Ref F5482-913Ref F5480-94Ref F5521-02Ref F5388-04Ref F5884O07Ref F5483-17Ref F5410-92Ref F5419-03Ref F5413-933Ref F5279-902Ref F5613-17Ref F5084-06Ref F5612-21Ref F5610-81Ref F5421-32Ref F5018-904Ref F5381-93Ref F5483-916Ref F5482-12Ref F5681-12Ref F5415-916Ref F5115-07Ref F5622-12Ref F5089-903Ref F5378-904Ref F5420-905Ref F5482-922Ref F5885O06Ref F5481-912Ref F5419-912Ref F5481-13Ref F5489-12Ref F5620-07Ref F5610-21Ref F5270-91Ref F5682-13Ref F5115-906Ref F5422-922Ref F5413-23Ref F5719O03Ref F5318-904Ref F5522-03Ref F5506-21Ref F5279-03Ref F5381-01Ref F5321-901Ref F5281-902Ref F5113-03Ref F5113-02Ref F5473-927Ref F5714O06Ref F5779O02Ref F5713O07Ref F5313-93Ref F5413-12Ref F5520-20Ref F5512-21Ref F5273-91Ref F5423-13Ref F5470-94Ref F5779O03Ref F5089-03Ref F5473-02Ref F5773O03Ref F5415-17Ref F5775O06Ref F5471-93Ref F5473-916Ref F5420-906Ref F5420-05Ref F5414-907Ref F5513-07Ref F5419-902Ref F5481-913Ref F5414-06Ref F5674-06Ref F5414-906Ref F5419-02Ref F5780O05Ref F5679-02Ref F5722O03Ref F5182-03Ref F5414-16Ref F5883O07Ref F5274-07Ref F5113-06Ref F5481-03Ref F5621-12Ref F5274-906Ref F5322-01Ref F5679-03Ref F5774O06Ref F5275-906Ref F5483-27Ref F5060-00Ref F5620-06Ref F5421-923Ref F5713O02Ref F5713O06Ref F5111-91Ref F5881O03Ref F5181-02Ref F5482-912Ref F5483-922Ref F5606-21Ref F5273-06Ref F5078-04Ref F5482-902Ref F5411-92Ref F5781O02Ref F5482-22Ref F5612-81Ref F5413-22Ref F2484I05Ref F5482-23Ref F5481-922Ref F5620-82
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Orthodontic Brackets EUDAMEDBRACKETS POS 18 H/W T-7 2nd BIC U/R FDA UDI
- Model / Reference
- F5423-12 EUDAMEDF5613-13 EUDAMEDF5281-903 EUDAMEDF5413-32 EUDAMEDF5615-06 EUDAMEDF5420-07 EUDAMEDF5782O02 EUDAMEDF5274-06 EUDAMEDF5471-91 EUDAMEDF5513-02 EUDAMEDF5473-23 EUDAMEDF5673-13 EUDAMEDF5410-81 EUDAMEDF5413-13 EUDAMEDF5889O03 EUDAMEDF5483-906 EUDAMEDF5413-932 EUDAMEDF5415-16 EUDAMEDF5173-06 EUDAMEDF5414-07 EUDAMEDF5514-06 EUDAMEDF5621-13 EUDAMEDF5415-906 EUDAMEDF5113-906 EUDAMEDF5383-93 EUDAMEDF5320-93 EUDAMEDF5773O02 EUDAMEDF5473-912 EUDAMEDF5273-07 EUDAMEDF5481-923 EUDAMEDF5481-12 EUDAMEDF5273-906 EUDAMEDF5122-03 EUDAMEDF5421-13 EUDAMEDF5489-16 EUDAMEDF5489-13 EUDAMEDF5414-916 EUDAMEDF5315-93 EUDAMEDF5413-936 EUDAMEDF5421-922 EUDAMEDF5483-94 EUDAMEDF5311-93 EUDAMEDF5173-03 EUDAMEDF5173-906 EUDAMEDF5078-904 EUDAMEDF5122-02 EUDAMEDF5884O06 EUDAMEDF5473-913 EUDAMEDF5882O02 EUDAMEDF5422-23 EUDAMEDF5673-12 EUDAMEDF5673-17 EUDAMEDF5675-07 EUDAMEDF5773O07 EUDAMEDF5473-917 EUDAMEDF5175-07 EUDAMEDF5382-01 EUDAMEDF5070-93 EUDAMEDF5373-93 EUDAMEDF5273-907 EUDAMEDF5423-17 EUDAMEDF5328-04 EUDAMEDF5889O02 EUDAMEDF5089-902 EUDAMEDF5380-93 EUDAMEDF5422-22 EUDAMEDF5113-907 EUDAMEDF5481-92 EUDAMEDF5613-12 EUDAMEDF5713O03 EUDAMEDF5606-81 EUDAMEDF5473-12 EUDAMEDF5310-93 EUDAMEDF5489-912 EUDAMEDF5719O02 EUDAMEDF5513-06 EUDAMEDF5481-23 EUDAMEDF5483-23 EUDAMEDF5473-17 EUDAMEDF5181-902 EUDAMEDF5513-03 EUDAMEDF5080-915 EUDAMEDF5515-06 EUDAMEDF5485-906 EUDAMEDF5179-903 EUDAMEDF5413-26 EUDAMEDF5473-922 EUDAMEDF5274-907 EUDAMEDF5378-04 EUDAMEDF5415-907 EUDAMEDF5483-926 EUDAMEDF5482-13 EUDAMEDF5119-02 EUDAMEDF5883O03 EUDAMEDF5413-922 EUDAMEDF5480-91 EUDAMEDF5485-07 EUDAMEDF5483-923 EUDAMEDF5473-06 EUDAMEDF5720O05 EUDAMEDF5119-903 EUDAMEDF5173-907 EUDAMEDF5483-07 EUDAMEDF5413-916 EUDAMEDF5473-926 EUDAMEDF5011-93 EUDAMEDF5470-93 EUDAMEDF5482-03 EUDAMEDF5410-94 EUDAMEDF5282-03 EUDAMEDF5774O07 EUDAMEDF5775O07 EUDAMEDF5175-907 EUDAMEDF5522-02 EUDAMEDF5422-13 EUDAMEDF5782O03 EUDAMEDF5482-913 EUDAMEDF5480-94 EUDAMEDF5521-02 EUDAMEDF5388-04 EUDAMEDF5884O07 EUDAMEDF5483-17 EUDAMEDF5410-92 EUDAMEDF5419-03 EUDAMEDF5413-933 EUDAMEDF5279-902 EUDAMEDF5613-17 EUDAMEDF5084-06 EUDAMEDF5612-21 EUDAMEDF5610-81 EUDAMEDF5421-32 EUDAMEDF5018-904 EUDAMEDF5381-93 EUDAMEDF5483-916 EUDAMEDF5482-12 EUDAMEDF5681-12 EUDAMEDF5415-916 EUDAMEDF5115-07 EUDAMEDF5622-12 EUDAMEDF5089-903 EUDAMEDF5378-904 EUDAMEDF5420-905 EUDAMEDF5482-922 EUDAMEDF5885O06 EUDAMEDF5481-912 EUDAMEDF5419-912 EUDAMEDF5481-13 EUDAMEDF5489-12 EUDAMEDF5620-07 EUDAMEDF5610-21 EUDAMEDF5270-91 EUDAMEDF5682-13 EUDAMEDF5115-906 EUDAMEDF5422-922 EUDAMEDF5413-23 EUDAMEDF5719O03 EUDAMEDF5318-904 EUDAMEDF5522-03 EUDAMEDF5506-21 EUDAMEDF5279-03 EUDAMEDF5381-01 EUDAMEDF5321-901 EUDAMEDF5281-902 EUDAMEDF5113-03 EUDAMEDF5113-02 EUDAMEDF5473-927 EUDAMEDF5714O06 EUDAMEDF5779O02 EUDAMEDF5713O07 EUDAMEDF5313-93 EUDAMEDF5413-12 EUDAMEDF5520-20 EUDAMEDF5512-21 EUDAMEDF5273-91 EUDAMEDF5423-13 EUDAMEDF5470-94 EUDAMEDF5779O03 EUDAMEDF5089-03 EUDAMEDF5473-02 EUDAMEDF5773O03 EUDAMEDF5415-17 EUDAMEDF5775O06 EUDAMEDF5471-93 EUDAMEDF5473-916 EUDAMEDF5420-906 EUDAMEDF5420-05 EUDAMEDF5414-907 EUDAMEDF5513-07 EUDAMEDF5419-902 EUDAMEDF5481-913 EUDAMEDF5414-06 EUDAMEDF5674-06 EUDAMEDF5414-906 EUDAMEDF5419-02 EUDAMEDF5780O05 EUDAMEDF5679-02 EUDAMEDF5722O03 EUDAMEDF5182-03 EUDAMEDF5414-16 EUDAMEDF5883O07 EUDAMEDF5274-07 EUDAMEDF5113-06 EUDAMEDF5481-03 EUDAMEDF5621-12 EUDAMEDF5274-906 EUDAMEDF5322-01 EUDAMEDF5679-03 EUDAMEDF5774O06 EUDAMEDF5275-906 EUDAMEDF5483-27 EUDAMEDF5060-00 EUDAMEDF5620-06 EUDAMEDF5421-923 EUDAMEDF5713O02 EUDAMEDF5713O06 EUDAMEDF5111-91 EUDAMEDF5881O03 EUDAMEDF5181-02 EUDAMEDF5482-912 EUDAMEDF5483-922 EUDAMEDF5606-21 EUDAMEDF5273-06 EUDAMEDF5078-04 EUDAMEDF5482-902 EUDAMEDF5411-92 EUDAMEDF5781O02 EUDAMEDF5482-22 EUDAMEDF5612-81 EUDAMEDF5413-22 EUDAMEDF2484I05 EUDAMEDFDA UDIF5482-23 EUDAMEDF5481-922 EUDAMEDF5620-82 EUDAMED
- Description
- BRACKETS POS 18 H/W T-7 2nd BIC U/R FDA UDI
Identifiers
- Catalog Number
- F2484I05 FDA UDI
- Primary DI / UDI-DI
- 08033707049500 EUDAMED08033707087779 EUDAMED08033707048022 EUDAMED08033707048602 EUDAMED08033707087823 EUDAMED08033707049067 EUDAMED08033707096351 EUDAMED08033707047865 EUDAMED08033707049753 EUDAMED08033707093763 EUDAMED08033707049876 EUDAMED08033707087977 EUDAMED08033707048398 EUDAMED08033707048534 EUDAMED08033707096702 EUDAMED08033707050469 EUDAMED08033707048763 EUDAMED08033707048909 EUDAMED08033707047452 EUDAMED08033707048817 EUDAMED08033707093824 EUDAMED08033707087939 EUDAMED08033707048923 EUDAMED08033707047155 EUDAMED08033707048350 EUDAMED08033707048138 EUDAMED08033707096375 EUDAMED08033707049944 EUDAMED08033707047803 EUDAMED08033707050186 EUDAMED08033707050070 EUDAMED08033707047834 EUDAMED08033707047384 EUDAMED08033707049159 EUDAMED08033707050667 EUDAMED08033707050650 EUDAMED08033707048862 EUDAMED08033707048107 EUDAMED08033707048787 EUDAMED08033707049265 EUDAMED08033707050575 EUDAMED08033707048084 EUDAMED08033707047445 EUDAMED08033707047490 EUDAMED08033707046882 EUDAMED08033707047377 EUDAMED08033707096733 EUDAMED08033707049951 EUDAMED08033707096658 EUDAMED08033707049357 EUDAMED08033707087960 EUDAMED08033707087991 EUDAMED08033707088035 EUDAMED08033707096436 EUDAMED08033707049975 EUDAMED08033707047575 EUDAMED08033707048336 EUDAMED08033707046851 EUDAMED08033707048251 EUDAMED08033707047841 EUDAMED08033707049531 EUDAMED08033707048213 EUDAMED08033707096696 EUDAMED08033707047056 EUDAMED08033707048299 EUDAMED08033707049340 EUDAMED08033707047162 EUDAMED08033707050162 EUDAMED08033707087762 EUDAMED08033707096535 EUDAMED08033707087717 EUDAMED08033707049821 EUDAMED08033707048077 EUDAMED08033707050681 EUDAMED08033707096542 EUDAMED08033707093800 EUDAMED08033707050100 EUDAMED08033707050414 EUDAMED08033707049852 EUDAMED08033707047698 EUDAMED08033707093770 EUDAMED08033707046929 EUDAMED08033707093848 EUDAMED08033707050605 EUDAMED08033707047643 EUDAMED08033707048589 EUDAMED08033707049982 EUDAMED08033707047896 EUDAMED08033707048275 EUDAMED08033707048930 EUDAMED08033707050551 EUDAMED08033707050230 EUDAMED08033707047278 EUDAMED08033707096689 EUDAMED08033707048725 EUDAMED08033707050025 EUDAMED08033707050599 EUDAMED08033707050544 EUDAMED08033707049807 EUDAMED08033707096566 EUDAMED08033707047308 EUDAMED08033707047506 EUDAMED08033707050353 EUDAMED08033707048701 EUDAMED08033707050001 EUDAMED08033707046707 EUDAMED08033707049739 EUDAMED08033707050216 EUDAMED08033707048435 EUDAMED08033707048046 EUDAMED08033707096450 EUDAMED08033707096474 EUDAMED08033707047599 EUDAMED08033707093749 EUDAMED08033707049333 EUDAMED08033707096368 EUDAMED08033707050292 EUDAMED08033707050049 EUDAMED08033707093725 EUDAMED08033707048374 EUDAMED08033707096740 EUDAMED08033707050391 EUDAMED08033707048411 EUDAMED08033707048978 EUDAMED08033707048770 EUDAMED08033707047971 EUDAMED08033707087793 EUDAMED08033707046967 EUDAMED08033707087748 EUDAMED08033707087731 EUDAMED08033707049180 EUDAMED08033707046721 EUDAMED08033707048329 EUDAMED08033707050513 EUDAMED08033707050223 EUDAMED08033707088103 EUDAMED08033707048947 EUDAMED08033707047230 EUDAMED08033707087946 EUDAMED08033707047063 EUDAMED08033707048282 EUDAMED08033707049074 EUDAMED08033707050308 EUDAMED08033707096757 EUDAMED08033707050148 EUDAMED08033707049029 EUDAMED08033707050087 EUDAMED08033707050643 EUDAMED08033707087892 EUDAMED08033707087724 EUDAMED08033707047759 EUDAMED08033707088134 EUDAMED08033707047247 EUDAMED08033707049425 EUDAMED08033707048572 EUDAMED08033707096559 EUDAMED08033707048121 EUDAMED08033707093756 EUDAMED08033707093688 EUDAMED08033707047964 EUDAMED08033707048305 EUDAMED08033707048152 EUDAMED08033707048015 EUDAMED08033707047100 EUDAMED08033707047094 EUDAMED08033707050018 EUDAMED08033707096597 EUDAMED08033707096399 EUDAMED08033707096580 EUDAMED08033707048091 EUDAMED08033707048527 EUDAMED08033707093718 EUDAMED08033707093701 EUDAMED08033707047858 EUDAMED08033707049517 EUDAMED08033707049746 EUDAMED08033707096405 EUDAMED08033707047049 EUDAMED08033707049784 EUDAMED08033707096382 EUDAMED08033707048916 EUDAMED08033707096467 EUDAMED08033707049760 EUDAMED08033707049968 EUDAMED08033707049081 EUDAMED08033707049043 EUDAMED08033707048855 EUDAMED08033707093817 EUDAMED08033707049005 EUDAMED08033707050155 EUDAMED08033707048800 EUDAMED08033707088004 EUDAMED08033707048848 EUDAMED08033707048961 EUDAMED08033707096412 EUDAMED08033707088042 EUDAMED08033707096511 EUDAMED08033707047728 EUDAMED08033707048824 EUDAMED08033707096726 EUDAMED08033707047872 EUDAMED08033707047117 EUDAMED08033707050063 EUDAMED08033707087922 EUDAMED08033707047889 EUDAMED08033707048176 EUDAMED08033707088066 EUDAMED08033707096443 EUDAMED08033707047926 EUDAMED08033707050438 EUDAMED08033707046837 EUDAMED08033707087885 EUDAMED08033707049272 EUDAMED08033707096528 EUDAMED08033707096573 EUDAMED08033707047087 EUDAMED08033707096641 EUDAMED08033707047674 EUDAMED08033707050285 EUDAMED08033707050537 EUDAMED08033707087700 EUDAMED08033707047797 EUDAMED08033707046875 EUDAMED08033707050261 EUDAMED08033707048459 EUDAMED08033707096337 EUDAMED08033707050247 EUDAMED08033707087755 EUDAMED08033707048565 EUDAMED08033707042884 EUDAMEDFDA UDI08033707050254 EUDAMED08033707050179 EUDAMED08033707087915 EUDAMED
- Basic UDI-DI
- B-08033707049500 EUDAMEDB-08033707087779 EUDAMEDB-08033707048022 EUDAMEDB-08033707048602 EUDAMEDB-08033707087823 EUDAMEDB-08033707049067 EUDAMEDB-08033707096351 EUDAMEDB-08033707047865 EUDAMEDB-08033707049753 EUDAMEDB-08033707093763 EUDAMEDB-08033707049876 EUDAMEDB-08033707087977 EUDAMEDB-08033707048398 EUDAMEDB-08033707048534 EUDAMEDB-08033707096702 EUDAMEDB-08033707050469 EUDAMEDB-08033707048763 EUDAMEDB-08033707048909 EUDAMEDB-08033707047452 EUDAMEDB-08033707048817 EUDAMEDB-08033707093824 EUDAMEDB-08033707087939 EUDAMEDB-08033707048923 EUDAMEDB-08033707047155 EUDAMEDB-08033707048350 EUDAMEDB-08033707048138 EUDAMEDB-08033707096375 EUDAMEDB-08033707049944 EUDAMEDB-08033707047803 EUDAMEDB-08033707050186 EUDAMEDB-08033707050070 EUDAMEDB-08033707047834 EUDAMEDB-08033707047384 EUDAMEDB-08033707049159 EUDAMEDB-08033707050667 EUDAMEDB-08033707050650 EUDAMEDB-08033707048862 EUDAMEDB-08033707048107 EUDAMEDB-08033707048787 EUDAMEDB-08033707049265 EUDAMEDB-08033707050575 EUDAMEDB-08033707048084 EUDAMEDB-08033707047445 EUDAMEDB-08033707047490 EUDAMEDB-08033707046882 EUDAMEDB-08033707047377 EUDAMEDB-08033707096733 EUDAMEDB-08033707049951 EUDAMEDB-08033707096658 EUDAMEDB-08033707049357 EUDAMEDB-08033707087960 EUDAMEDB-08033707087991 EUDAMEDB-08033707088035 EUDAMEDB-08033707096436 EUDAMEDB-08033707049975 EUDAMEDB-08033707047575 EUDAMEDB-08033707048336 EUDAMEDB-08033707046851 EUDAMEDB-08033707048251 EUDAMEDB-08033707047841 EUDAMEDB-08033707049531 EUDAMEDB-08033707048213 EUDAMEDB-08033707096696 EUDAMEDB-08033707047056 EUDAMEDB-08033707048299 EUDAMEDB-08033707049340 EUDAMEDB-08033707047162 EUDAMEDB-08033707050162 EUDAMEDB-08033707087762 EUDAMEDB-08033707096535 EUDAMEDB-08033707087717 EUDAMEDB-08033707049821 EUDAMEDB-08033707048077 EUDAMEDB-08033707050681 EUDAMEDB-08033707096542 EUDAMEDB-08033707093800 EUDAMEDB-08033707050100 EUDAMEDB-08033707050414 EUDAMEDB-08033707049852 EUDAMEDB-08033707047698 EUDAMEDB-08033707093770 EUDAMEDB-08033707046929 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EUDAMEDB-08033707048978 EUDAMEDB-08033707048770 EUDAMEDB-08033707047971 EUDAMEDB-08033707087793 EUDAMEDB-08033707046967 EUDAMEDB-08033707087748 EUDAMEDB-08033707087731 EUDAMEDB-08033707049180 EUDAMEDB-08033707046721 EUDAMEDB-08033707048329 EUDAMEDB-08033707050513 EUDAMEDB-08033707050223 EUDAMEDB-08033707088103 EUDAMEDB-08033707048947 EUDAMEDB-08033707047230 EUDAMEDB-08033707087946 EUDAMEDB-08033707047063 EUDAMEDB-08033707048282 EUDAMEDB-08033707049074 EUDAMEDB-08033707050308 EUDAMEDB-08033707096757 EUDAMEDB-08033707050148 EUDAMEDB-08033707049029 EUDAMEDB-08033707050087 EUDAMEDB-08033707050643 EUDAMEDB-08033707087892 EUDAMEDB-08033707087724 EUDAMEDB-08033707047759 EUDAMEDB-08033707088134 EUDAMEDB-08033707047247 EUDAMEDB-08033707049425 EUDAMEDB-08033707048572 EUDAMEDB-08033707096559 EUDAMEDB-08033707048121 EUDAMEDB-08033707093756 EUDAMEDB-08033707093688 EUDAMEDB-08033707047964 EUDAMEDB-08033707048305 EUDAMEDB-08033707048152 EUDAMEDB-08033707048015 EUDAMEDB-08033707047100 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- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic tube
Orthodontic Brackets by Leone S.p.a. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
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- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707049500 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (234)
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