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DIATECH Diamonds
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 60032494Model DIATECH Diamond InstrumentsRef 60032420Ref 60032458Ref 60032002Ref 60031765Ref 60031830Ref 60032116Ref 60032024Ref 60031782Ref 60032430
by Dent4You AG
Identity
- Trade Name
- DIATECH Diamonds EUDAMEDFDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- DIATECH Diamonds, G845 Flat End Taper 014-04.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G846 Flat End Taper 018-07.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G392 Interproximal 016-08.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G835R Rounded Edge Cylinder 014-04.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G860 Flame 012-05.0-F, FG, 5pcs FDA UDIDIATECH Diamonds, G862 Flame 014-08.0-F, FG, 5pcs FDA UDIDIATECH Diamonds, G877K Tapered Torpedo/Curettage 012-06.0-M, FG, 50pcs FDA UDIDIATECH Diamonds, G835 Flat End Cylinder 008-03.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G379 Egg/Football 016-03.5-EF, FG, 5pcs FDA UDIDIATECH Diamonds, G368 Bud/Pointed Football 020-05.0-F, FG, 50pcs FDA UDIDIATECH Diamonds, G859 Needle 018-10.0-EF, FG, 5pcs FDA UDI
- Model / Reference
- 60032116 EUDAMEDFDA UDI60031830 EUDAMEDFDA UDI60032024 EUDAMEDFDA UDI60032430 EUDAMEDFDA UDI60032458 EUDAMEDFDA UDI60032494 EUDAMEDFDA UDI60032002 EUDAMEDFDA UDI60031782 EUDAMEDFDA UDI60031765 EUDAMEDFDA UDI60032420 EUDAMEDFDA UDIDIATECH Diamond Instruments EUDAMED60032100 FDA UDI
- Description
- DIATECH Diamonds, G845 Flat End Taper 014-04.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G846 Flat End Taper 018-07.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G392 Interproximal 016-08.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G835R Rounded Edge Cylinder 014-04.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G860 Flame 012-05.0-F, FG, 5pcs FDA UDIDIATECH Diamonds, G862 Flame 014-08.0-F, FG, 5pcs FDA UDIDIATECH Diamonds, G877K Tapered Torpedo/Curettage 012-06.0-M, FG, 50pcs FDA UDIDIATECH Diamonds, G835 Flat End Cylinder 008-03.0-M, FG, 5pcs FDA UDIDIATECH Diamonds, G379 Egg/Football 016-03.5-EF, FG, 5pcs FDA UDIDIATECH Diamonds, G368 Bud/Pointed Football 020-05.0-F, FG, 50pcs FDA UDIDIATECH Diamonds, G859 Needle 018-10.0-EF, FG, 5pcs FDA UDI
Identifiers
- Catalog Number
- 60032100 FDA UDI60032116 FDA UDI60031830 FDA UDI60032024 FDA UDI60032430 FDA UDI60032458 FDA UDI60032494 FDA UDI60032002 FDA UDI60031782 FDA UDI60031765 FDA UDI60032420 FDA UDI
- Primary DI / UDI-DI
- 07630243615858 EUDAMEDFDA UDI07630243612994 EUDAMEDFDA UDI07630243619221 EUDAMEDFDA UDI07630243619580 EUDAMEDFDA UDI07630243614714 EUDAMEDFDA UDI07630243612369 EUDAMEDFDA UDI07630243618842 EUDAMEDFDA UDI07630243661169 EUDAMED07630243658763 EUDAMED07630243665174 EUDAMED07630243615698 FDA UDI07630243614936 FDA UDI07630243618941 FDA UDI07630243612536 FDA UDI
- Basic UDI-DI
- 76303929ROTA20011CP EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
DIATECH Diamonds by Dent4You AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Diamond dental bur, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (21)
- FDA UDI c6974509-686e-4a2d-ad1e-4a0feafd37a5 35 fields · synced Sep 30, 2026
- FDA UDI 9a08e3a2-c9af-42ef-9a7a-227dbb5e2f4e 35 fields · synced May 25, 2026
- FDA UDI e21ac37d-b4da-4beb-9a2f-50629d94636a 35 fields · synced May 27, 2026
- FDA UDI ba1f5e54-db5f-4e0e-9262-981f0ba42e96 35 fields · synced May 29, 2026
- FDA UDI ea2488a2-9465-439d-bd6e-3ffa4dd897f7 35 fields · synced May 30, 2026
- FDA UDI 28c196d6-5f87-453c-9ed8-4268c9dbf0c7 35 fields · synced May 30, 2026
- FDA UDI a6d7b448-d592-49ac-9b96-3a5d713441e8 35 fields · synced May 30, 2026
- FDA UDI b0015552-a932-4c48-9a42-e5d0d1fd8916 35 fields · synced May 30, 2026
- FDA UDI 90126fa7-63ee-45d6-96fe-2877065ca341 35 fields · synced May 30, 2026
- FDA UDI 4ace0b35-72a0-4444-a60e-31d8ead76b9f 35 fields · synced May 30, 2026
- FDA UDI 55733802-36b2-474e-b793-d23ec0bb2b81 35 fields · synced May 30, 2026
- EUDAMED ebe6588c-7b37-4ab8-bc76-fb593db015b3 61 fields · synced Jul 8, 2026
- EUDAMED b0e089c7-7f0f-47f4-be2e-8b0f685cc26b 61 fields · synced Jul 8, 2026
- EUDAMED 9162ff2c-7810-4730-ad65-2844ebf6c5b3 61 fields · synced Jul 8, 2026
- EUDAMED 7ff31042-2797-4e89-9f5c-b3f9d78a1883 61 fields · synced Jul 8, 2026
- EUDAMED fb0d1a24-aefa-418b-9180-76683a4bef8d 61 fields · synced Jul 8, 2026
- EUDAMED d75862d8-64fa-4ad2-9186-45894b3c6630 61 fields · synced Jul 8, 2026
- EUDAMED be425530-8803-4b8a-85c9-3d3f8f636197 61 fields · synced Aug 1, 2026
- EUDAMED 7eff69b1-f45a-4c09-a491-bad4b86113fe 61 fields · synced Aug 1, 2026
- EUDAMED 5eb2c60b-3291-4620-bea7-c7f8a1b80741 61 fields · synced Sep 17, 2026
- EUDAMED bdf8ed2b-6834-4604-916c-f657a08b8def 61 fields · synced Sep 17, 2026