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
407.02D periost. elevator goldmanfox d	407.02D	EUDAMED	Class I	Active
156.78 elevator light handle n° 78	156.78	EUDAMED	Class I	Active
MIRROR TI PLAN 5 SS Box of 12 KENT	MP3524KENT	EUDAMED	Class I	Active
Dental mirrors and handles	MP1320PH	EUDAMED	Class I	Active
3041.U5 impres.trayretent type 2/n°5 up 71x60mm	3041.U5	EUDAMED	Class I	Active
201.22D instr. almagam westcott 22 d	201.22D	EUDAMED	Class I	Active
173.00XL amalg foc 0 dbl serrated d	173.00XL	EUDAMED	Class I	Active
photomirror occl. adult ti	MZP511.	EUDAMEDFDA UDI	Class I	Active
mirror plan ss rh5 x12	MP3324PH	EUDAMED	Class I	Active
290.17 Molar Forceps Upper A	290.17	EUDAMED	Class I	Active
156.62 elevator light handle n° 62	156.62	EUDAMED	Class I	Active
221.05 tweezers college checkered 5	221.05	EUDAMED	Class I	Active
193.02TD spatula heidemann 2 ti d	193.02TD	EUDAMED	Class I	Active
3041.U3 impres.trayretent type 2/n°3 up 66x53mm	3041.U3	EUDAMED	Class I	Active
291.37 Child Forceps Sup. Incisors	291.37	EUDAMED	Class I	Active
262.05XL probe simple 5 xl	262.05XL	EUDAMED	Class I	Active
Dental mirrors and handles	MP3122PHVRAC	EUDAMED	Class I	Active
170.10XL amalg instr 10 dbl serrated d	170.10XL	EUDAMED	Class I	Active
mirror plan ss alu3 x12	MP3126PH	EUDAMED	Class I	Active
156.72 elevator light handle n° 72	156.72	EUDAMED	Class I	Active
204.02XL spatula double (w.h.e.) 2 xl	204.02XL	EUDAMED	Class I	Active
407.01D periost. elevator pr.benque d	407.01D	EUDAMED	Class I	Active
135.86D curette dbl lucas86 d	135.86D	EUDAMED	Class I	Active
405.04SI curette m23 xl	405.04SI	EUDAMEDFDA UDI	Class I	Active
262.09xlk Sple Xl Probe N° 9 Brand Kit	262.09XLK	EUDAMED	Class I	Active
3040.U2 impres.tray type 1/n°2 up 64x51mm	3040.U2	EUDAMED	Class I	Active
404.08XL scaler double ck6 xl	404.08XL	EUDAMED	Class I	Active
photomirror lingual fine pr	MZP546.	EUDAMED	Class I	Active
Dental mirrors and handles	210.00SI	EUDAMED	Class I	Active
652.00TC scissors metzenbaum crv14cm tc	652.00TC	EUDAMED	Class I	Active
111.00XL BURNISHER QUADRUPLE Benett Design	111.00XL	EUDAMED	Class I	Active
mirror plan rh4 x20	MPV3122PH	EUDAMED	Class I	Active
204.07XL spatula double (w.h.e.) 5 xl	204.07XL	EUDAMED	Class I	Active
107.33D BURNISHER XLStyle	107.33D	EUDAMED	Class I	Active
262.08D probe simple 8 design	262.08D	EUDAMED	Class I	Active
curette dbl hemingway1 d	135.01D	EUDAMED	Class I	Active
156.50 elevator light handle n° 50	156.50	EUDAMED	Class I	Active
mirror plan css rh4 x12	MP4322PH	EUDAMED	Class I	Active
photomirror lateral pr	MZP566.	EUDAMED	Class I	Active
220.01 tweezers college smooth n° 1	220.01	EUDAMED	Class I	Active
205.02xl Spatula Double Dirigo (w.d.) N° 2 Xl	205.02XL	EUDAMED	Class I	Active
1290.75 forceps low canine/bicuspid satin	1290.75	EUDAMEDFDA UDI	Class I	Active
262.05D probe simple 5 design	262.05D	EUDAMED	Class I	Active
1290.13 forceps low canine/bicuspid satin	1290.13	EUDAMEDFDA UDI	Class I	Active
193.01D spatula dble heidemann 1 d	193.01D	EUDAMED	Class I	Active
262.06D probe simple 6 design	262.06D	EUDAMED	Class I	Active
170.48D amalg instr 17 dbl serrated xl	170.48D	EUDAMED	Class I	Active
162.00D excavator dbl darbyperry fine	162.00D	EUDAMED	Class I	Active
3050.U2 imp.tray full ret type 3/n°2 up 64x51mm	3050.U2	EUDAMED	Class I	Active
163.14XL excavator dbl white14 xl	163.14XL	EUDAMED	Class I	Active

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