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
Prodont-Holliger	150.01XL	FDA UDI	Class I	Active
Prodont-Holliger	MP4303PH	FDA UDI	Class I	Active
Prodont-Holliger	MP4305PH	FDA UDI	Class I	Active
Prodont-Holliger	150.01D	FDA UDI	Class I	Active
Prodont-Holliger	150.03XL	FDA UDI	Class I	Active
straight convex conical osteotome - ø3, 7 mm 4, 2 mm	355.05	EUDAMED	Class I	Active
170.01D instr. double temp.fillings d	170.01D	EUDAMED	Class I	Active
164.23D excavator dbl ash22 xl	164.23D	EUDAMED	Class I	Active
623.00 scissors -micro- straight 9cm	623.00	EUDAMED	Class I	Active
235.05 syndesmotome blades - standard - n° 5	235.05	EUDAMED	Class I	Active
photomirror lingual large ti	MZP551.	EUDAMEDFDA UDI	Class I	Active
222.09 tweezers surgical 18cm	222.09	EUDAMED	Class I	Active
165.03SI excavator dble n° 2 bliss	165.03SI	EUDAMEDFDA UDI	Class I	Active
1290.73 forceps lower molars satin	1290.73	EUDAMEDFDA UDI	Class I	Active
248.00 spatula for sculting	248.00	EUDAMED	Class I	Active
237.01 syndesmotome fixed handle 1	237.01	EUDAMED	Class I	Active
173.04D amalg foc 3 dbl smooth xl	173.04D	EUDAMED	Class I	Active
295.02 Davier Child A/Spring First	295.02	EUDAMED	Class I	Active
406.06XL curette langer 5-6	406.06XL	EUDAMED	Class I	Active
149.16 elevator vignal lancet16	149.16	EUDAMED	Class I	Active
402.11TXL curette perio gracey11/12 bliss	402.11TXL	EUDAMED	Class I	Active
262.20dk Sple Probe N° 20 Design Kit	262.20DK	EUDAMED	Class I	Active
290.22 Lower Molar Forceps	290.22	EUDAMED	Class I	Active
162.05D excavator dbl darbyperry5 d	162.05D	EUDAMED	Class I	Active
263.07XL probe double 7 xl	263.07XL	EUDAMED	Class I	Active
208.06XL spatula double (l.s.p.) d	208.06XL	EUDAMED	Class I	Active
mirror dblsided ss rh5 x12	MP7324PH	EUDAMED	Class I	Active
Dental mirrors and handles	13313	EUDAMED	Class I	Active
183.06D scalers i.n.a. design	183.06D	EUDAMED	Class I	Active
252.06D cement spatula double design	252.06D	EUDAMED	Class I	Active
154.03D gingiv. retrac. instr. w/o saw edge d	154.03D	EUDAMED	Class I	Active
248.24XL cement spatula simple xl	248.24XL	EUDAMED	Class I	Active
154.02D gingival retraction thread w/saw edge d	154.02D	EUDAMED	Class I	Active
407.15D Burnisher spoon	407.15D	EUDAMED	Class I	Active
252.16XL cement spatula double xl	252.16XL	EUDAMED	Class I	Active
290.04 Incisal And Canine Forceps In	290.04	EUDAMED	Class I	Active
156.63 elevator light handle n° 63	156.63	EUDAMED	Class I	Active
630.00 scissors gfx curved 13cm	630.00	EUDAMED	Class I	Active
156.59 elevator light handle n° 59	156.59	EUDAMED	Class I	Active
photomirror vestibular ti	MZP531.	EUDAMEDFDA UDI	Class I	Active
photomirror big1 142x75x70chro	MZP572.	EUDAMED	Class I	Active
1291.62 forceps up roots	1291.62	EUDAMED	Class I	Active
418.05D probe graduated 1mm	418.05D	EUDAMED	Class I	Active
3041.L6 impres.tray retentiv type 2/n°6 low78x61	3041.L6	EUDAMED	Class I	Active
mirrors pure reflect plan 5 x12	MP3624PH	EUDAMED	Class I	Active
Dental mirrors and handles	MP1328PH	EUDAMED	Class I	Active
170.13XL amalg instr 13 dbl serrated d	170.13XL	EUDAMED	Class I	Active
170.48XL BURNISHER - QUADRUPLE - Design	170.48XL	EUDAMED	Class I	Active
407.06XL mini retractor for papilla	407.06XL	EUDAMED	Class I	Active
621.00TC. scissors strt finepoint10.5cmtc	621.00TC.	EUDAMED	Class I	Active

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