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
Precimatrix steel ring	PR0MATS001	EUDAMED	Class I	Active
contoured anatomical matrices	6114	EUDAMEDFDA UDI	Class I	Active
Roeko Steel matrix band	590506	EUDAMED	Class I	Active
API autoclavable placement instrument	6851	EUDAMEDFDA UDI	Class I	Active
wood wedges	5017S	EUDAMEDFDA UDI	Class I	Active
tofflemire matrices	5920	EUDAMEDFDA UDI	Class I	Active
Quickmat transparent sectional matrices	5776	EUDAMEDFDA UDI	Class I	Active
Roeko Steel matrix band soft	591505	EUDAMED	Class I	Active
tofflemire matrices	6102	EUDAMEDFDA UDI	Class I	Active
myWedge	7101	EUDAMEDFDA UDI	Class I	Active
Kent Dental Interdental Wedges	3134153	EUDAMED	Class I	Active
Maxi ID-Rings	5364	EUDAMEDFDA UDI	Class I	Active
SwissMat bands	41902	EUDAMED	Class I	Active
Precimatrix NiTi ring	PR0MATN001	EUDAMED	Class I	Active
Precimatrix steel ring kit	PR0MATSKIT	EUDAMED	Class I	Active
stop card	530080	EUDAMED	Class I	Active
sectional restorative trial set	1092	EUDAMEDFDA UDI	Class I	Active
wood wedges	5001	EUDAMEDFDA UDI	Class I	Active
Junior Quickmat sectional matrices	S01758	EUDAMED	Class I	Active
myQuickmat Classico kit	6801	EUDAMEDFDA UDI	Class I	Active
Strip soft	5276	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5786	EUDAMEDFDA UDI	Class I	Active
SwissMat tines	41917	EUDAMED	Class I	Active
Stripmat	5010	EUDAMEDFDA UDI	Class I	Active
3wedge	7504	EUDAMEDFDA UDI	Class I	Active
Unica Proximal Deep anterior matrices	6952	EUDAMEDFDA UDI	Class I	Active
Quickmat All-Round trial molar and premolar	1096	EUDAMEDFDA UDI	Class I	Active
the wedge	7001	EUDAMEDFDA UDI	Class I	Active
myWedge	7103	EUDAMEDFDA UDI	Class I	Active
anterior dispens-O-mat	5221	EUDAMEDFDA UDI	Class I	Active
Precimatrix Cunei Legno	PR0MATCL12	EUDAMED	Class I	Active
anatomic superthin matrices	5717	EUDAMEDFDA UDI	Class I	Active
maximat plus autoclavable spools	S01601	EUDAMED	Class I	Active
contoured tofflemire matrices	6109	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6716	EUDAMEDFDA UDI	Class I	Active
Fiber-Splint ortho evolution	5979	EUDAMEDFDA UDI	Class IIa	Active
endo-stops	5310	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5796	EUDAMEDFDA UDI	Class I	Active
Cotton Roll Holder	5405	EUDAMEDFDA UDI	Class I	Active
orange wood wedges	5018S	EUDAMEDFDA UDI	Class I	Active
Polishing strip fine 30 µm	5511	EUDAMEDFDA UDI	Class I	Active
maximat plus pre-loaded	5126	EUDAMEDFDA UDI	Class I	Active
Quickmat deluxe kit	5701	EUDAMEDFDA UDI	Class I	Active
Kent Dental Interdental Wedges	3134150	EUDAMED	Class I	Active
myTines Prime	6892	EUDAMEDFDA UDI	Class I	Active
tofflemire matrices	6101	EUDAMEDFDA UDI	Class I	Active
QuickmatFIT anatomical sectional matrices	5836	EUDAMEDFDA UDI	Class I	Active
ID-Rings	5319	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6735	EUDAMEDFDA UDI	Class I	Active
Kent Dental Interdental Wedges	3134155	EUDAMED	Class I	Active

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