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
endo-stops	5301	EUDAMEDFDA UDI	Class I	Active
myTines large	6306	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5367	EUDAMEDFDA UDI	Class I	Active
contoured transparent matrices	6140	EUDAMEDFDA UDI	Class I	Active
Unica Proximal anterior matrices	6914	EUDAMEDFDA UDI	Class I	Active
Simplee Premolar Sectional Matrix Bands	156124	EUDAMED	Class I	Active
myTines Junior	6333	EUDAMEDFDA UDI	Class I	Active
Quickmat Sectional Matrices	S01501	EUDAMEDFDA UDI	Class I	Active
transparent wedges	5902	EUDAMEDFDA UDI	Class I	Active
QuickmatFLEX Trial	1098	EUDAMEDFDA UDI	Class I	Active
Roeko Stopper	331000	EUDAMED	Class I	Active
Lumicontrast sectional matrices	6715	EUDAMEDFDA UDI	Class I	Active
contoured tofflemire matrices	6106	EUDAMEDFDA UDI	Class I	Active
tria-shine	5504	EUDAMEDFDA UDI	Class I	Active
Kent Dental Interdental Wedges	3134154	EUDAMED	Class I	Active
maximat plus spools	5122	EUDAMEDFDA UDI	Class I	Active
siqveland matrices	5727	EUDAMEDFDA UDI	Class I	Active
Prodonto MATRIXMART Linea Matrici	PROB40005MM6	EUDAMED	Class I	Active
myClip Junior	S01760	EUDAMED	Class I	Active
myRing Classico	6814	EUDAMEDFDA UDI	Class I	Active
Quickmat All-round circumferential posterior matrices	6866	EUDAMEDFDA UDI	Class I	Active
Stripmat	5006	EUDAMEDFDA UDI	Class I	Active
myWedge	M01899	EUDAMEDFDA UDI	Class I	Active
myWedge	7400	EUDAMEDFDA UDI	Class I	Active
myJunior kit	6330	EUDAMEDFDA UDI	Class I	Active
Prodonto Anello per matrici sezionali	PROB4RINGTIPS	EUDAMED	Class I	Active
stop card	5300/5	EUDAMEDFDA UDI	Class I	Active
Precimatrix NiTi ring Kit	PR0MATNKIT	EUDAMED	Class I	Active
myWedge	M01901	EUDAMED	Class I	Active
Junior Lumicontrast sectional matrices	6708	EUDAMEDFDA UDI	Class I	Active
myQuickmat Forte starter kit	6883	EUDAMEDFDA UDI	Class I	Active
SwissMat V-wedges	41909	EUDAMED	Class I	Active
myTines Medium	M01894	EUDAMEDFDA UDI	Class I	Active
Softrix	5908	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6756	EUDAMEDFDA UDI	Class I	Active
Unica master kit	6901	EUDAMEDFDA UDI	Class I	Active
Strip ST	5236	EUDAMEDFDA UDI	Class I	Active
tofflemire matrices	6104	EUDAMEDFDA UDI	Class I	Active
clearmat transparent matrices	5919	EUDAMEDFDA UDI	Class I	Active
Kent Dental Interdental Wedges	3134151	EUDAMED	Class I	Active
stop card	5300/2	EUDAMEDFDA UDI	Class I	Active
F-Splint-Aid Slim	5977	EUDAMEDFDA UDI	Class IIa	Active
ID-Rings	5315	EUDAMEDFDA UDI	Class I	Active
ID-Rings	5312	EUDAMEDFDA UDI	Class I	Active
Lumicontrast anterior strip	6960	EUDAMEDFDA UDI	Class I	Active
QuickmatFIT anatomical sectional matrices	5806	EUDAMEDFDA UDI	Class I	Active
wood wedges	5040	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5365	EUDAMEDFDA UDI	Class I	Active
contoured anatomical matrices	6113	EUDAMEDFDA UDI	Class I	Active
Quickmat All-round circumferential posterior matrices	6865	EUDAMEDFDA UDI	Class I	Active

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