Question 1

What types of medical devices does Prodont-Holliger manufacture?

Accepted Answer

Prodont-Holliger specializes in dental instruments used for both surgical and restorative procedures. Their portfolio includes reusable dental mirrors for intraoral examination, dental elevators and osteotomes for sinus lifts and extractions, as well as precision tools like syndesmotome blades, surgical tweezers, excavators, and specialized photomirrors. These devices are designed to support procedures such as tooth removal, bone preparation, and detailed dental assessments.

Question 2

Where is Prodont-Holliger based, and what regulatory markets do they serve?

Accepted Answer

Prodont-Holliger is headquartered in France. Their devices are authorized in the European Union and the United States, where they comply with regulatory requirements for medical devices. The company maintains listings for its products in EUDAMED (the EU’s medical device registry) and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and transparency in both markets.

Question 3

How are Prodont-Holliger’s devices classified under EU and US regulations?

Accepted Answer

All of Prodont-Holliger’s listed devices fall under Class I classification in both the EU and the US regulatory frameworks. This classification applies to low-risk devices, such as dental instruments, where the risk of harm to patients is minimal. Class I devices typically require fewer regulatory controls but still must meet essential safety and performance requirements before being authorized for market placement.

Question 4

Which registries or databases list Prodont-Holliger’s medical devices?

Accepted Answer

Prodont-Holliger’s devices are officially listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s UDI system, which tracks device identifiers in the United States. These listings ensure that authorized devices can be traced and verified by healthcare providers, regulators, and other stakeholders in their respective markets.

Device	Model / Reference	Registries	Class	Status
159.77 elevator light finger rest 77	159.77	EUDAMED	Class I	Active
261GPR3 gingiprotect 3, 7mm	261GPR3	EUDAMED	Class I	Active
Mirror Ti Plane 5 Double Face Css Box 6	MPP8524PH	EUDAMEDFDA UDI	Class I	Active
1291.60 foceps sup. roots extra thin beak	1291.60	EUDAMED	Class I	Active
237.02 syndesmotome fixed handle 2	237.02	EUDAMED	Class I	Active
149.07 elevator vignal n 7	149.07	EUDAMED	Class I	Active
193.00XL spatula double heidemann 0 xl	193.00XL	EUDAMED	Class I	Active
395.00 cutter spoon - bone	395.00	EUDAMED	Class I	Active
106.28XL burnisher design	106.28XL	EUDAMED	Class I	Active
mirror pure reflect p1 css x12	MP4616PH	EUDAMED	Class I	Active
235.06 syndesmotome blades - standard - n° 6	235.06	EUDAMED	Class I	Active
angled convex conical osteotome - ø1, 7 mm 2, 3 mm	352.01.	EUDAMED	Class I	Active
photomirror big2 142x85x75chro	MZP582.	EUDAMED	Class I	Active
405.13SI curette columbia 4l-4r	405.13SI	EUDAMEDFDA UDI	Class I	Active
Mirrors Dms. Rh Magnifying N° 4 - Ss X 12	MP103422PH	EUDAMED	Class I	Active
Mirror Rh Plane 4 Double Face Css Box 6	MPP8322PH	EUDAMED	Class I	Active
291.22 Child Molar Forceps Inf	291.22	EUDAMED	Class I	Active
170.00D instrument f/ temp. fillings d	170.00D	EUDAMED	Class I	Active
193.01TD spatula heidemann 1 ti d	193.01TD	EUDAMED	Class I	Active
406.09SI instr.dble n128-l5 bliss	406.09SI	EUDAMEDFDA UDI	Class I	Active
402.15SI curette dbl 13/14 xl	402.15SI	EUDAMEDFDA UDI	Class I	Active
mirror plan rh5 x20	MPV3124PH	EUDAMED	Class I	Active
623.00TC scissors micro curved 9cm tc	623.00TC	EUDAMED	Class I	Active
156.56 elevator light handle n° 56	156.56	EUDAMED	Class I	Active
3040.L6D impres.tray half type 1/n°6 lower right	3040.L6D	EUDAMED	Class I	Active
159.60 elevator light finger rest 60	159.60	EUDAMED	Class I	Active
Mirror HOLY ALU BACK SURFACE PLANE N° 4 - SIMPLE STEM (S.S.)	MP105122PH	EUDAMED	Class I	Active
407.14D INSTRUMENT - DOUBLE FOR AMALGAMS JLM6ED XLStyle	407.14D	EUDAMED	Class I	Active
403.17XL curette dbl mccall13/14 xl	403.17XL	EUDAMED	Class I	Active
220.02S. tweezers smooth 2 satin	220.02S.	EUDAMED	Class I	Active
653.00 scissors mayo straight 14cm	653.00	EUDAMED	Class I	Active
263.05XL probe double 5 xl	263.05XL	EUDAMED	Class I	Active
170.16D AMALGAM INSTRUMENT - DOUBLE - SERRATED - XLStyle	170.16D	EUDAMED	Class I	Active
263.05dk Dble Probe N°5 Design For Kit	263.05DK	EUDAMED	Class I	Active
235.01 syndesmotome blades - standard - n° 1	235.01	EUDAMED	Class I	Active
419.02SI burnisher machtou 1-1 bliss	419.02SI	EUDAMEDFDA UDI	Class I	Active
173.02D amalg foc 1 dbl serrated xl	173.02D	EUDAMED	Class I	Active
173.03XL amalg foc 3 dbl smooth d	173.03XL	EUDAMED	Class I	Active
156.53 elevator light handle n° 53	156.53	EUDAMED	Class I	Active
193.10XL spatula for obturation	193.10XL	EUDAMED	Class I	Active
mirror mag.ss rh4 x12	MP3422PH	EUDAMED	Class I	Active
291.33 Davier Child Roots Inf.	291.33	EUDAMED	Class I	Active
154.03XL gingival retrac. thread w/o saw edge xl	154.03XL	EUDAMED	Class I	Active
Dental mirrors and handles	MP2320PH	EUDAMED	Class I	Active
156.64 elevator light handle n° 64	156.64	EUDAMED	Class I	Active
mirrors alu plan 0 ss x12	MP3114PH	EUDAMED	Class I	Active
162.02XL excavator dbl darbyperry2 xl	162.02XL	EUDAMED	Class I	Active
208.01XL spatula double (l.s.p.) design	208.01XL	EUDAMED	Class I	Active
photomirror occl. child ti	MZP521.	EUDAMEDFDA UDI	Class I	Active
Dental mirrors and handles	MP3340PH	EUDAMED	Class I	Active

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