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
Delta Silicone Tubes (Small)	S01534	EUDAMED	Class I	Active
ID-Rings	5311	EUDAMEDFDA UDI	Class I	Active
myRing Classico	6804	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5360	EUDAMEDFDA UDI	Class I	Active
Prodonto Strip abrasiva	PROCT0001G	EUDAMED	Class I	Active
myWedge	7113	EUDAMEDFDA UDI	Class I	Active
Prodonto Cunei interdentali in legno	PROB40002XXS	EUDAMED	Class I	Active
Diamond24	S01746	EUDAMED	Class I	Active
wood wedges	5017	EUDAMEDFDA UDI	Class I	Active
R&S Coins interdentaires transparents	3113054	EUDAMED	Class I	Active
myRing Forte	6806	EUDAMEDFDA UDI	Class I	Active
Fiber-Splint one-layer	5970	EUDAMEDFDA UDI	Class IIa	Active
Prodonto Strip abrasiva	PROCT0001F	EUDAMED	Class I	Active
myWedge	7111	EUDAMEDFDA UDI	Class I	Active
the wedge	7011	EUDAMEDFDA UDI	Class I	Active
stop card	5300/7	EUDAMEDFDA UDI	Class I	Active
Unica minideep Anterior	S01770	EUDAMED	Class I	Active
tria-shine combi-pack	5507	EUDAMEDFDA UDI	Class I	Active
endo-stops	5302	EUDAMEDFDA UDI	Class I	Active
contoured transparent matrices	6141	EUDAMEDFDA UDI	Class I	Active
Precimatrix Cunei Legno	PR0MATCL13	EUDAMED	Class I	Active
maximat plus spools	5121	EUDAMEDFDA UDI	Class I	Active
anatomic superthin matrices	5713	EUDAMEDFDA UDI	Class I	Active
Wood wedges	S01051	EUDAMED	Class I	Active
transparent wedges	5923	EUDAMEDFDA UDI	Class I	Active
ID-Rings	5316	EUDAMEDFDA UDI	Class I	Active
maximat plus autoclavable spools	5127	EUDAMEDFDA UDI	Class I	Active
The Wedge	M01362	EUDAMED	Class I	Active
ID-Rings	5322	EUDAMEDFDA UDI	Class I	Active
wood wedges	5013S	EUDAMEDFDA UDI	Class I	Active
anterior dispens-O-mat	5222	EUDAMEDFDA UDI	Class I	Active
myWedge	7102	EUDAMEDFDA UDI	Class I	Active
unica anterior	6912	EUDAMEDFDA UDI	Class I	Active
wood wedges	5001S	EUDAMEDFDA UDI	Class I	Active
contoured anatomical matrices	6116	EUDAMEDFDA UDI	Class I	Active
anatomic superthin matrices	5718	EUDAMEDFDA UDI	Class I	Active
QuickmatFLEX sectional matrices	S01783	EUDAMED	Class I	Active
myClip Junior	6335	EUDAMEDFDA UDI	Class I	Active
R&S Interdental wood wedges	3134148	EUDAMED	Class I	Active
Polishing strip coarse 60 µm	5502	EUDAMEDFDA UDI	Class I	Active
Prodonto MATRIXMART Linea Matrici	PROB40005MM10	EUDAMED	Class I	Active
myRing Forte	6816	EUDAMEDFDA UDI	Class I	Active
Quickring forceps	5702	EUDAMEDFDA UDI	Class I	Active
the wedge	7013	EUDAMEDFDA UDI	Class I	Active
Unica Proximal Deep anterior matrices	6953	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5363	EUDAMEDFDA UDI	Class I	Active
myRing Junior	6336	EUDAMEDFDA UDI	Class I	Active
anatomic superthin matrices	5719	EUDAMEDFDA UDI	Class I	Active
LumiContrast Sectional Matrices	S01675	EUDAMED	Class I	Active
ID-Rings	5320	EUDAMEDFDA UDI	Class I	Active

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