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
201.22XL instr. almagam westcott 22 xl	201.22XL	EUDAMED	Class I	Active
106.28D spatula double for cement	106.28D	EUDAMED	Class I	Active
264.12 syndes./periotome blade 1mm	264.12	EUDAMED	Class I	Active
419.04XL burnisher machtou 2-4 bliss	419.04XL	EUDAMED	Class I	Active
201.20D instr. almagam westcott 20 d	201.20D	EUDAMED	Class I	Active
159.74 Elevator With Light Ergonomic Handle N° 74	159.74	EUDAMED	Class I	Active
MIRROR RH PLAN 0 CSS Box of 12	MP4314PH	EUDAMED	Class I	Active
199.00D spatula composit angled rightd	199.00D	EUDAMED	Class I	Active
246.18XL cement spatula spl flexible xl	246.18XL	EUDAMED	Class I	Active
429.00 tweezers w/eyelets 15cm	429.00	EUDAMED	Class I	Active
628.00 scissors joseph straight 14cm	628.00	EUDAMED	Class I	Active
235.08 syndesmotome blades - standard - n° 8	235.08	EUDAMED	Class I	Active
156.AV elevator cambray front 2 mm	156.AV	EUDAMED	Class I	Active
MIRROR ALU PLAN 1 CSS Box of 12	MP4116PH	EUDAMED	Class I	Active
mirrors pure reflect plan 1 x12	MP3616PH	EUDAMED	Class I	Active
MIRROR ALU PLAN 5 SS Box of 12 KENT	MP3124KENT	EUDAMED	Class I	Active
159.63 elevator light finger rest 63	159.63	EUDAMED	Class I	Active
237.11 syndesmotome fixed handle 11	237.11	EUDAMED	Class I	Active
414.13D curette surgical	414.13D	EUDAMED	Class I	Active
173.02XL amalg foc 2 dbl serrated d	173.02XL	EUDAMED	Class I	Active
620.01 scissors gencives curved 11cm	620.01	EUDAMED	Class I	Active
263.06SI probe double 11/12 bliss	263.06SI	EUDAMEDFDA UDI	Class I	Active
165.01XL excavator dble n° 1	165.01XL	EUDAMED	Class I	Active
curette granulation spoon design	131.02D	EUDAMED	Class I	Active
159.5C curved luxation instr. 5mm	159.5C	EUDAMED	Class I	Active
106.29D burnisher sple n° 28 xl	106.29D	EUDAMED	Class I	Active
410.13D SCALER - Zerfing Design	410.13D	EUDAMED	Class I	Active
159.67 elevator light finger rest 67	159.67	EUDAMED	Class I	Active
655.00 scissors curved pointed 13cm	655.00	EUDAMED	Class I	Active
MIRROR ALU MAG. 4 SS Box of 12 KENT	MP3222KENT	EUDAMED	Class I	Active
222.10 tweezer adson 12 cm	222.10	EUDAMED	Class I	Active
246.10D cement spatula simple design	246.10D	EUDAMED	Class I	Active
mirrors alu plan 1 ss x12	MP3116PH	EUDAMED	Class I	Active
237.09 syndesmotome fixed handle 9	237.09	EUDAMED	Class I	Active
curette chompret xlstyle	134.01XL	EUDAMED	Class I	Active
curette dbl hemingway2 xl	135.02XL	EUDAMED	Class I	Active
angled convex conical osteotome - ø2, 7 mm 3, 2 mm	352.03.	EUDAMED	Class I	Active
162.02D excavator dbl darbyperry2 d	162.02D	EUDAMED	Class I	Active
263.23XL probe double 23 xl	263.23XL	EUDAMED	Class I	Active
164.17XL excavator dbl ash17 d	164.17XL	EUDAMED	Class I	Active
263.07SI probe double 23/17 bliss	263.07SI	EUDAMEDFDA UDI	Class I	Active
162.05XL excavator dbl darbyperry5 xl	162.05XL	EUDAMED	Class I	Active
angled convex conical osteotome - ø4, 2 mm 5 mm	352.06	EUDAMED	Class I	Active
173.05D amalg foc 4 dbl smooth xl	173.05D	EUDAMED	Class I	Active
402.07XL curette dbl gracey7/8 ti xl	402.07XL	EUDAMED	Class I	Active
Dental mirrors and handles	MP3305PH	EUDAMED	Class I	Active
MIRROR DMS ALU MAG. 3 SS Box of 12	MP103220PH	EUDAMED	Class I	Active
224.02. tweezer fine bites	224.02.	EUDAMED	Class I	Active
MIRROR ALU PLAN 4 SS Box of 12 RS	MP3122RS	EUDAMED	Class I	Active
mirror plan css ti5 x12	MP4524PH	EUDAMEDFDA UDI	Class I	Active

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