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
406.10XL CURETTE LANGER 5-6 Mini	406.10XL	EUDAMED	Class I	Active
156.55 elevator light handle n° 55	156.55	EUDAMED	Class I	Active
3040.L6 impres. tray type 1/n°6 lower 78x61mm	3040.L6	EUDAMED	Class I	Active
mirror plan ss ti3 x12	MP3520PH	EUDAMED	Class I	Active
246.09SI cement spatula sple n° 9 bliss	246.09SI	EUDAMEDFDA UDI	Class I	Active
246.18TD cement spatula sple n° 18 ti d	246.18TD	EUDAMED	Class I	Active
173.03D amalg foc 2 dbl serrated xl	173.03D	EUDAMED	Class I	Active
photomirror lingual fin ti	MZP541.	EUDAMEDFDA UDI	Class I	Active
Amalgam instruments	191.03XL	EUDAMED	Class I	Active
149.21 elevator vignal 21	149.21	EUDAMEDFDA UDI	Class I	Active
straight convex conical osteotome - ø2, 7 mm 3, 2 mm	355.03	EUDAMED	Class I	Active
156.69 elevator light handle n° 69	156.69	EUDAMED	Class I	Active
159.56 elevator light finger rest 56	159.56	EUDAMED	Class I	Active
170.14XL amalg instr 14 dbl serrated d	170.14XL	EUDAMED	Class I	Active
185.03D SCALERS Darby-Perry Design	185.03D	EUDAMED	Class I	Active
MIRROR ALU MAG. 5 SS Box of 12 KENT	MP3224KENT	EUDAMED	Class I	Active
290.79 Lower Wisdom Teeth Forceps	290.79	EUDAMED	Class I	Active
straight convex osteotome - ø5 mm	353.05	EUDAMED	Class I	Active
219.02 tweezers college dbl curv 2	219.02	EUDAMED	Class I	Active
curette chompret2 design	134.02D	EUDAMED	Class I	Active
Dental mirrors and handles	MP1403PH	EUDAMED	Class I	Active
173.04XL amalg foc 4 dbl smooth d	173.04XL	EUDAMED	Class I	Active
295.06 Davier Child A/ Spring Molair	295.06	EUDAMED	Class I	Active
149.10 elevator vignal lancet10	149.10	EUDAMED	Class I	Active
163.20D excavator dbl white19 xl	163.20D	EUDAMED	Class I	Active
162.07D excavator dbl darbyperry7 d	162.07D	EUDAMED	Class I	Active
curette chompret1 design	134.01D	EUDAMED	Class I	Active
Dental mirrors and handles	MP2318PH	EUDAMED	Class I	Active
curette chompret xlstyle	134.05XL	EUDAMED	Class I	Active
straight concave osteotome - ø5 mm	354.05	EUDAMED	Class I	Active
3041.U6 impres.trayretent type 2/n°6 up 73x62mm	3041.U6	EUDAMED	Class I	Active
mirror plastic plan alu4 x36	MP8122MPH	EUDAMED	Class I	Active
Dental mirrors and handles	MP3140PH	EUDAMED	Class I	Active
mirror rh5 plan ss x20	MPV3324PH	EUDAMED	Class I	Active
Mirror Titanium Double Face 4 Ss Box Of 6	MP7622PH	EUDAMED	Class I	Active
296.03 forceps child nospring up root	296.03	EUDAMED	Class I	Active
154.04d Instr.margin Protect Pr Taille Prothese	154.04D	EUDAMED	Class I	Active
183.07D scalers i.n.a. design	183.07D	EUDAMED	Class I	Active
625.00 scissors pointed straight 11cm	625.00	EUDAMED	Class I	Active
156.75 elevator light handle n° 75	156.75	EUDAMED	Class I	Active
3050.U6 impres.tray full type 3/n°6 up 73x62	3050.U6	EUDAMED	Class I	Active
3040.L2D impres.tray half type 1/n°2 upper right	3040.L2D	EUDAMED	Class I	Active
246.13XL cement spatula simple xl	246.13XL	EUDAMED	Class I	Active
209.02D instr. dble amalgam ladmore2 d	209.02D	EUDAMED	Class I	Active
262.20D probe simple 20 handle design	262.20D	EUDAMED	Class I	Active
mirror dblsided css pr4 x12	MP8722PH	EUDAMED	Class I	Active
201.22DR instr. wescott n° 22 design ø2	201.22DR	EUDAMED	Class I	Active
1290.18 forceps up left molars satin	1290.18	EUDAMEDFDA UDI	Class I	Active
photomirror vestibul.chro	MZP532.	EUDAMED	Class I	Active
208.03D spatula double (l.s.p.) design	208.03D	EUDAMED	Class I	Active

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