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
NiTi Ring	S01851	EUDAMED	Class I	Active
myForceps	5707	EUDAMEDFDA UDI	Class I	Active
Stripmat anatomic	5225	EUDAMEDFDA UDI	Class I	Active
wood wedges	5015S	EUDAMEDFDA UDI	Class I	Active
myWedge	7112	EUDAMEDFDA UDI	Class I	Active
SwissMat bands	41905	EUDAMED	Class I	Active
myClip 2.0 + myTines Medium	S01728M	EUDAMED	Class I	Active
Anterior Master Mix	6999	EUDAMEDFDA UDI	Class I	Active
Quickmat Prime	1202	EUDAMED	Class I	Active
endo-stops	5303	EUDAMEDFDA UDI	Class I	Active
orange wood wedges	5018MN	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6705	EUDAMEDFDA UDI	Class I	Active
myQuickmat Forte kit	6803	EUDAMEDFDA UDI	Class I	Active
3wedge	7501	EUDAMEDFDA UDI	Class I	Active
QuickmatFIT anatomical sectional matrices	5835	EUDAMEDFDA UDI	Class I	Active
wood wedges	5017PLUS	EUDAMEDFDA UDI	Class I	Active
myRing Classico	S01731	EUDAMED	Class I	Active
QuickmatFLEX sectional matrices	6796	EUDAMEDFDA UDI	Class I	Active
stop card	530060	EUDAMED	Class I	Active
Roeko-Strip	600009	EUDAMED	Class I	Active
myWedge	7104	EUDAMEDFDA UDI	Class I	Active
Strip ST	5235	EUDAMEDFDA UDI	Class I	Active
endo-stops	5307	EUDAMEDFDA UDI	Class I	Active
3wedge	7502	EUDAMEDFDA UDI	Class I	Active
contoured anatomical matrices	6215	EUDAMEDFDA UDI	Class I	Active
stop card	5300/8	EUDAMEDFDA UDI	Class I	Active
endo-stops	5304	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5756	EUDAMEDFDA UDI	Class I	Active
ID-Rings	5317	EUDAMEDFDA UDI	Class I	Active
transparent wedges	5903	EUDAMEDFDA UDI	Class I	Active
tria-shine	5505	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5368	EUDAMEDFDA UDI	Class I	Active
myRing Forte + myTines Small	S01735S	EUDAMED	Class I	Active
contoured anatomical matrices	6217	EUDAMEDFDA UDI	Class I	Active
Quickmat Silicone tubes	S01505	EUDAMED	Class I	Active
stop card	530020	EUDAMED	Class I	Active
Junior Quickmat sectional matrices	5708	EUDAMEDFDA UDI	Class I	Active
unica anterior trial	1093	EUDAMEDFDA UDI	Class I	Active
Precimatrix Cunei Legno	PR0MATCL11	EUDAMED	Class I	Active
Quickmat Sectional Matrices	S01502	EUDAMED	Class I	Active
pinky wood wedges	S01050	EUDAMEDFDA UDI	Class I	Active
endo-stops	5308	EUDAMEDFDA UDI	Class I	Active
fiber-Splint ML multi-layer	5971	EUDAMEDFDA UDI	Class IIa	Active
Prodonto MATRIXMART Linea matrici	PROB40003MM5	EUDAMED	Class I	Active
Simplee NiTi ring	156121	EUDAMED	Class I	Active
clearmat transparent matrices	5915	EUDAMEDFDA UDI	Class I	Active
Fiber bond	6525	EUDAMED	Class IIa	Active
Roeko Steel matrix band soft	591507	EUDAMED	Class I	Active
Unica anterior introkit	6900	EUDAMEDFDA UDI	Class I	Active
clearmat transparent matrices	5914	EUDAMEDFDA UDI	Class I	Active

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