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
3040.U1 impres.tray type 1/n°1 up 61x47mm	3040.U1	EUDAMED	Class I	Active
156.66 elevator light handle n° 66	156.66	EUDAMED	Class I	Active
246.20TXL cement spatula sple n° 20 ti xl	246.20TXL	EUDAMED	Class I	Active
164.22D excavator dbl ash21 xl	164.22D	EUDAMED	Class I	Active
290.08 Lower Premolar Davier	290.08	EUDAMED	Class I	Active
162.07XL excavator dbl darbyperry7 xl	162.07XL	EUDAMED	Class I	Active
mirror plan ss ti4 x12	MP3522PH	EUDAMED	Class I	Active
mirrors ss alu mag. 6 x12	MP3226PH	EUDAMED	Class I	Active
159.59 elevator light finger rest 59	159.59	EUDAMED	Class I	Active
3041.L4S impression tray, half up left type 2/n°4 retentive edges	3041.L4S	EUDAMED	Class I	Active
mirror pure reflect p2 css x12	MP4618PH	EUDAMED	Class I	Active
291.67 Upper Wisdom Teeth Davier	291.67	EUDAMED	Class I	Active
159.73 elevator light finger rest 73	159.73	EUDAMED	Class I	Active
290.07 Upper Premolar Davier	290.07	EUDAMED	Class I	Active
227.04 tweezers - self closing	227.04	EUDAMED	Class I	Active
149.34 elevator vignal 34	149.34	EUDAMED	Class I	Active
418.06SI probe, graduations n°6 bliss	418.06SI	EUDAMEDFDA UDI	Class I	Active
straight convex conical osteotome - ø2, 3 mm 2, 7 mm	355.02.	EUDAMED	Class I	Active
227.00 tweezers meriam	227.00	EUDAMED	Class I	Active
262.19d Probe - Simple - Handle Design N° 19	262.19D	EUDAMED	Class I	Active
268.02D probe - double - briault b11	268.02D	EUDAMED	Class I	Active
184.04D scalers jaquette design	184.04D	EUDAMED	Class I	Active
194.15XL modeling instr. n4	194.15XL	EUDAMED	Class I	Active
Dental mirrors and handles	MP1324PH	EUDAMED	Class I	Active
3040.U5 impres.tray type 1/n°5 up 71x60mm	3040.U5	EUDAMED	Class I	Active
162.06D excavator dbl darbyperry6 d	162.06D	EUDAMED	Class I	Active
straight convex conical osteotome - ø4, 2 mm 5 mm	355.06	EUDAMED	Class I	Active
222.12 tweezer adson 12 cm	222.12	EUDAMED	Class I	Active
262.01XL probe sple n° 1 xl	262.01XL	EUDAMED	Class I	Active
404.05XL scaler dble minick6 crv xl ti	404.05XL	EUDAMED	Class I	Active
curette granulation spoon design	131.03D	EUDAMED	Class I	Active
266.03XL probe simple rhein n°3 xl	266.03XL	EUDAMED	Class I	Active
235.23 syndesmotome blades -fine - n° 23	235.23	EUDAMED	Class I	Active
174.08XL amalg instr 9 dbl smooth d	174.08XL	EUDAMED	Class I	Active
3040.L2S impression tray half type 1/n°2 up left	3040.L2S	EUDAMED	Class I	Active
407.12XL periosteal elevator papilla xl	407.12XL	EUDAMED	Class I	Active
MIRROR HOLY ALU MAG. 3 SS Box of 12	MP105320PH	EUDAMED	Class I	Active
Dental mirrors and handles	210.00D	EUDAMED	Class I	Active
Dental mirrors and handles	MP3240PH	EUDAMED	Class I	Active
183.02D scalers i.n.a. design	183.02D	EUDAMED	Class I	Active
164.21XL excavator dbl ash21 d	164.21XL	EUDAMED	Class I	Active
291.38 Child Forceps Inf. Incisors	291.38	EUDAMED	Class I	Active
269.03XL probe dble paro curved xl gr	269.03XL	EUDAMED	Class I	Active
angled convex conical osteotome - ø3, 7 mm 4, 2 mm	352.05.	EUDAMED	Class I	Active
262.07XL probe - simple 7 handle xl	262.07XL	EUDAMED	Class I	Active
235.21 syndesmotome blades -fine - n° 21	235.21	EUDAMED	Class I	Active
156.40 elevator kopp left	156.40	EUDAMED	Class I	Active
163.19XL excavator dbl white19 d	163.19XL	EUDAMED	Class I	Active
3050.U1 imp.tray full ret type 3/n°1 up 61x47mm	3050.U1	EUDAMED	Class I	Active
Dental mirrors and handles	MP3310RPH	EUDAMED	Class I	Active

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