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
myWedge	M01900	EUDAMED	Class I	Active
Simplee Molar + Extension Sectional Matrix Bands	156122	EUDAMED	Class I	Active
Polydentia PRO	5720	EUDAMEDFDA UDI	Class I	Active
unica minideep trial	1094	EUDAMEDFDA UDI	Class I	Active
Quickmat All-round circumferential posterior matrices	S01829	EUDAMED	Class I	Active
Quickmat transparent sectional matrices	5766	EUDAMEDFDA UDI	Class I	Active
Quickmat Sectional Matrices	S01503	EUDAMED	Class I	Active
Quickmat All-round circumferential posterior matrices	6856	EUDAMEDFDA UDI	Class I	Active
QuickmatFLEX sectional matrices	6786	EUDAMEDFDA UDI	Class I	Active
myClip 2.0	6805	EUDAMEDFDA UDI	Class I	Active
R&S Interdental wood wedges	3134147	EUDAMED	Class I	Active
QuickmatFIT anatomical sectional matrices	5846	EUDAMEDFDA UDI	Class I	Active
Stripmat	5008	EUDAMEDFDA UDI	Class I	Active
contoured anatomical matrices	6115	EUDAMEDFDA UDI	Class I	Active
myWedge	7100	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5362	EUDAMEDFDA UDI	Class I	Active
stop card	5300/4	EUDAMEDFDA UDI	Class I	Active
contoured tofflemire matrices	6107	EUDAMEDFDA UDI	Class I	Active
tofflemire matrices	5921	EUDAMEDFDA UDI	Class I	Active
Roeko Abrasive Strip	560060	EUDAMED	Class I	Active
Precimatrix sectional matrices	PR0MAT004P	EUDAMED	Class I	Active
tria-shine	5506	EUDAMEDFDA UDI	Class I	Active
Clip&Splint	5975CS	EUDAMEDFDA UDI	Class I	Active
myQuickmat All-round introkit	6850	EUDAMEDFDA UDI	Class I	Active
Wood wedges	S01053	EUDAMED	Class I	Active
anatomic superthin matrices	5714	EUDAMEDFDA UDI	Class I	Active
Prodonto Matrici sezionali	PROB45736	EUDAMED	Class I	Active
stop card	530030	EUDAMEDFDA UDI	Class I	Active
Polishing strip medium 40 µm	5501	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5785	EUDAMEDFDA UDI	Class I	Active
Quickmat transparent sectional matrices	5765	EUDAMEDFDA UDI	Class I	Active
myRing Forte + myTines Medium	S01735M	EUDAMED	Class I	Active
Maxi ID-Rings	5366	EUDAMEDFDA UDI	Class I	Active
Quickrings & Re-force	5704	EUDAMEDFDA UDI	Class I	Active
The Wedge	M01360	EUDAMED	Class I	Active
Strip soft	5275	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5369	EUDAMEDFDA UDI	Class I	Active
unica anterior	6950	EUDAMEDFDA UDI	Class I	Active
Softrix	5906	EUDAMEDFDA UDI	Class I	Active
Prodonto MATRIXMART Linea matrici	PROB40003MM6	EUDAMED	Class I	Active
Delta tubes	5712	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6706	EUDAMEDFDA UDI	Class I	Active
Prodonto MATRIXMART Linea matrici	PROB40004MM7	EUDAMED	Class I	Active
Simplee NiTi ring kit	156120	EUDAMED	Class I	Active
The Wedge	M01361	EUDAMED	Class I	Active
Prodonto Matrici sezionali	PROB45706	EUDAMED	Class I	Active
Unica Proximal anterior matrices	6913	EUDAMEDFDA UDI	Class I	Active
stop card	5300/1	EUDAMEDFDA UDI	Class I	Active
maximat plus pre-loaded	5125	EUDAMEDFDA UDI	Class I	Active
Wood Wedges	S01052	EUDAMED	Class I	Active

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