Question 1

What types of medical devices does Polydentia SA manufacture?

Accepted Answer

Polydentia SA specialises in dental devices, producing single-use dental wedges like the Hemo-wedge, dentine bonding agents such as the Fiber-Bond series, and dental reinforcing fibres like the Fiber-Plast kits. These products are designed for restorative and orthodontic procedures, including bonding and reinforcing dental structures.

Question 2

Where is Polydentia SA based, and what does that mean for its regulatory compliance?

Accepted Answer

Polydentia SA is based in Switzerland, which means its devices must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) if applicable. Since its products are listed in EUDAMED, they are likely authorised under these frameworks, though compliance depends on individual device classifications (Class I, II, or IIa).

Question 3

Which regulatory registries list Polydentia SA’s devices, and why is that important?

Accepted Answer

Polydentia SA’s devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s Unique Device Identifier (UDI) system, meaning they are traceable under both EU and US regulatory oversight. This ensures transparency for healthcare providers, regulators, and patients, as it confirms the devices meet applicable safety and performance standards in those regions.

Question 4

How are Polydentia SA’s devices classified under EU and FDA regulations?

Accepted Answer

Polydentia SA’s devices fall into Class I, Class II, or Class IIa classifications. Class I devices (like some single-use wedges) pose minimal risk, while Class IIa (e.g., bonding agents) require additional safety controls. The classification determines regulatory scrutiny, with higher classes needing pre-market evaluations to ensure safety and performance before authorisation.

Device	Model / Reference	Registries	Class	Status
Roeko Abrasive Strip	560040	EUDAMED	Class I	Active
myWedge	M01898	EUDAMED	Class I	Active
SwissMat rings	41913	EUDAMED	Class I	Active
wood wedges	5013PLUS	EUDAMEDFDA UDI	Class I	Active
wood wedges	5015	EUDAMEDFDA UDI	Class I	Active
clearmat transparent matrices	5918	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5735	EUDAMEDFDA UDI	Class I	Active
Prodonto Cunei interdentali in legno	PROB40002L	EUDAMED	Class I	Active
3wedge	7505	EUDAMEDFDA UDI	Class I	Active
myClip 2.0	6305	EUDAMEDFDA UDI	Class I	Active
Forceps SwissMat	41901	EUDAMED	Class I	Active
clearmat transparent matrices	5917	EUDAMEDFDA UDI	Class I	Active
myQuickmat Classico starter kit	6881	EUDAMEDFDA UDI	Class I	Active
QuickmatFIT anatomical sectional matrices	5856	EUDAMEDFDA UDI	Class I	Active
QuickmatFLEX sectional matrices	6787	EUDAMEDFDA UDI	Class I	Active
Precimatrix sectional matrices	PR0MAT004D	EUDAMED	Class I	Active
Endostops	21407	EUDAMED	Class I	Active
QuickmatFLEX sectional matrices trial set	1095	EUDAMEDFDA UDI	Class I	Active
myQuickmat Prime kit	6890	EUDAMEDFDA UDI	Class I	Active
tofflemire matrices	6103	EUDAMEDFDA UDI	Class I	Active
Tofflemire matrices	S01060	EUDAMED	Class I	Active
Prodonto Tubi in silicone	PROB45712	EUDAMED	Class I	Active
Precimatrix sectional matrices	PR0MAT004M	EUDAMED	Class I	Active
maximat plus	5191	EUDAMEDFDA UDI	Class I	Active
Quickmat Prime	6893	EUDAMEDFDA UDI	Class I	Active
Quickmat Sectional Matrices	S01499	EUDAMED	Class I	Active
ID-Rings	5313	EUDAMEDFDA UDI	Class I	Active
Prodonto Cunei interdentali in legno	PROB40002ASS	EUDAMED	Class I	Active
Strip soft	5277	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6746	EUDAMEDFDA UDI	Class I	Active
wood wedges	5060	EUDAMEDFDA UDI	Class I	Active
Simplee interdental wood wedges	156063	EUDAMED	Class I	Active

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