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
296.02 forceps child nospring up premolar	296.02	EUDAMED	Class I	Active
636.00 scissors lagrange 11.5cm	636.00	EUDAMED	Class I	Active
Dental mirrors and handles	MP3528PH	EUDAMED	Class I	Active
252.05D cement spatula double design	252.05D	EUDAMED	Class I	Active
1291.67 forceps upper wisdoms, satin	1291.67	EUDAMED	Class I	Active
237.28 syndesmotome fixed handle 28	237.28	EUDAMED	Class I	Active
108.16XL burnisher double design	108.16XL	EUDAMED	Class I	Active
3040.L4D impres.tray half type 1/n°4 upper right	3040.L4D	EUDAMED	Class I	Active
296.06 forceps child nospring low molar	296.06	EUDAMED	Class I	Active
402.01TXL curette perio db gracey 1/2 bliss	402.01TXL	EUDAMED	Class I	Active
201.21XL instr. wescott n° 21 xl	201.21XL	EUDAMED	Class I	Active
Mirror Double Face Titanium Plane 5 Ss Box Of 12	MP7524PH	EUDAMED	Class I	Active
156.41 elevator kopp right	156.41	EUDAMED	Class I	Active
151.40 cheek retractor simple adult	151.40	EUDAMED	Class I	Active
Mirror Photo Rh Face Vestibulaire	MZP530.	EUDAMED	Class I	Active
3040.L6S impres.tray half type 1/n°6 lower left	3040.L6S	EUDAMED	Class I	Active
MIRROR HOLY ALU PLAN 3 SS Box of 12	MP105120PH	EUDAMED	Class I	Active
264.02 syndes. chompret2 plain handle	264.02	EUDAMED	Class I	Active
105.00 crown remover	105.00	EUDAMED	Class I	Active
252.07D cement spatula double design	252.07D	EUDAMED	Class I	Active
170.01XL instr.double cavity filling1 xl	170.01XL	EUDAMED	Class I	Active
mirrors alu plan ss 2 x12	MP3124PH	EUDAMED	Class I	Active
3040.L2 impres. tray type 1/n°2 low 60x49mm	3040.L2	EUDAMED	Class I	Active
201.21D instr.dble amalgam wescott21 d	201.21D	EUDAMED	Class I	Active
mirror rh plan 0 ss x12	MP3314PH	EUDAMED	Class I	Active
296.04 forceps child nospring up molar	296.04	EUDAMED	Class I	Active
246.19XL CEMENT SPATULA - SIMPLE - Extra-flexible XLStyle	246.19XL	EUDAMED	Class I	Active
185.04D SCALERS I.N.H. Design	185.04D	EUDAMED	Class I	Active
252.01D cement spatula double design	252.01D	EUDAMED	Class I	Active
262.23XL probe simple 23 xl	262.23XL	EUDAMED	Class I	Active
419.01SI Burnisher bowl/cone	419.01SI	EUDAMEDFDA UDI	Class I	Active
Amalgam instruments	192.02TD	EUDAMED	Class I	Active
149.11 elevator vignal lancet11	149.11	EUDAMED	Class I	Active
Amalgam instruments	186.93XL	EUDAMED	Class I	Active
194.13XL modeling instr. n2	194.13XL	EUDAMED	Class I	Active
156.77 elevator light handle n° 77	156.77	EUDAMED	Class I	Active
290.02 Incisal And Canine Davier Su	290.02	EUDAMED	Class I	Active
159.79 elevator luxateur light handle	159.79	EUDAMED	Class I	Active
Dental mirrors and handles	MP1126PH	EUDAMED	Class I	Active
402.13TXL2 curette perio gracey13/14 bliss	402.13TXL	EUDAMED	Class I	Active
295.04 Davier Child A/ Spring Molair	295.04	EUDAMED	Class I	Active
Dental mirrors and handles	MP2112PH	EUDAMED	Class I	Active
Dental mirrors and handles	MP3640PH	EUDAMED	Class I	Active
156.86 elevator coupland n°86	156.86	EUDAMED	Class I	Active
156.67 elevator light handle n° 67	156.67	EUDAMED	Class I	Active
curette dbl hemingway0 xl	135.00XL	EUDAMED	Class I	Active
156.70 Elevator Light Handle N° 70	156.70	EUDAMED	Class I	Active
3050.L2 imp.tray full ret type 3/n°2 low 60x49mm	3050.L2	EUDAMED	Class I	Active
263.05DG probe dble, rhein dg	263.05DG	EUDAMED	Class I	Active
169.01D BURNISHER QUADRUPLE Benett XLStyle	169.01D	EUDAMED	Class I	Active

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