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
156.68 elevator light handle n° 68	156.68	EUDAMED	Class I	Active
252.07XL cement spatula double xl	252.07XL	EUDAMED	Class I	Active
237.07 syndesmotome fixed handle 7	237.07	EUDAMED	Class I	Active
407.04D periosteal elevator hourigan d	407.04D	EUDAMED	Class I	Active
412.13XL curette surgical	412.13XL	EUDAMED	Class I	Active
170.14D amalg instr 13 dbl serrated xl	170.14D	EUDAMED	Class I	Active
curette chompret4 design	134.04D	EUDAMED	Class I	Active
263.05D probe double 5 design	263.05D	EUDAMED	Class I	Active
264.01 syndes. chompret1 plain handle	264.01	EUDAMED	Class I	Active
164.19XL excavator dbl ash19 d	164.19XL	EUDAMED	Class I	Active
149.17 elevator vignal 17	149.17	EUDAMED	Class I	Active
108.16D burnisher double xlstyle	108.16D	EUDAMED	Class I	Active
Mirror Double Face Titanium Plane 4 Ss Box Of 12	MP7522PH	EUDAMED	Class I	Active
291.62 Davier Superieure Roots Mor	291.62	EUDAMED	Class I	Active
407.07XL periosteal elevator molt7 xl	407.07XL	EUDAMED	Class I	Active
209.03D INSTRUMENT DOUBLE FOR AMALGAMS Ladmore Design	209.03D	EUDAMED	Class I	Active
149.03 elevator vignal lancet3	149.03	EUDAMED	Class I	Active
contrastor 5 large straight	MZP216	EUDAMED	Class I	Active
291.61 Davier Roots Sup. Short Bors	291.61	EUDAMED	Class I	Active
mirror pure reflect p0 css x12	MP4614PH	EUDAMED	Class I	Active
1291.51 forceps for upper roots, satin	1291.51	EUDAMED	Class I	Active
151.01 retractor dautrey large 14.3cm	151.01	EUDAMED	Class I	Active
291.13 forceps child low premolars	291.13	EUDAMED	Class I	Active
contrastor 3 73x70mm	MZP217	EUDAMED	Class I	Active
151.20 cheek retractor adult	151.20	EUDAMED	Class I	Active
222.07 tweezers strt cut 14cm	222.07	EUDAMED	Class I	Active
angled convex conical osteotome - ø2, 3 mm 2, 7 mm	352.02.	EUDAMED	Class I	Active
291.86 Lower Molar Forceps Ca	291.86	EUDAMED	Class I	Active
401.02XL scalers thorpe design	401.02XL	EUDAMED	Class I	Active
151.21 cheek retractor child	151.21	EUDAMED	Class I	Active
409.03D SCALER - Zerfing Design	409.03D	EUDAMED	Class I	Active
237.21 syndesmotome fixed handle 21	237.21	EUDAMED	Class I	Active
246.05SI cement spatula sple n° 5 bliss	246.05SI	EUDAMEDFDA UDI	Class I	Active
265.04 chompret syndesmotome handle, hollow	265.04	EUDAMED	Class I	Active
202.03XL INSTRUMENT FOR ALMAGAMSP.F.I.D. Design	202.03XL	EUDAMED	Class I	Active
262.08XL probe - simple 8 handle xl	262.08XL	EUDAMED	Class I	Active
149.09 Elevator Vignal N 9	149.09	EUDAMED	Class I	Active
1290.33 forceps for lower roots, satin	1290.33	EUDAMEDFDA UDI	Class I	Active
193.02D spatula dble heidemann 2 d	193.02D	EUDAMED	Class I	Active
angled concave osteotome - ø5 mm	351.05.	EUDAMED	Class I	Active
291.60 Davier Superieure Roots Mor	291.60	EUDAMED	Class I	Active
246.20D cement spatula spl flexible d	246.20D	EUDAMED	Class I	Active
158.01 elevator warwick-james n° 1	158.01	EUDAMED	Class I	Active
MIRROR DMS ALU MAG. 6 SS Box of 12	MP103226PH	EUDAMED	Class I	Active
183.34D scalers i.n.a. design	183.34D	EUDAMED	Class I	Active
159.71 elevator light finger rest 71	159.71	EUDAMED	Class I	Active
3050.L6 impres.tray full type 3/n°6 low 78x61	3050.L6	EUDAMED	Class I	Active
626.00 scissors pointed curved 11cm	626.00	EUDAMED	Class I	Active
Dental mirrors and handles	212.00D	EUDAMED	Class I	Active
170.02D instr. dble cavity n°2 d	170.02D	EUDAMED	Class I	Active

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