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
wood wedges	5012	EUDAMEDFDA UDI	Class I	Active
wood wedges	5013	EUDAMEDFDA UDI	Class I	Active
Strip 0.05	5256	EUDAMEDFDA UDI	Class I	Active
Prodonto MATRIXMART Linea matrici	PROB40003MM7	EUDAMED	Class I	Active
myTines GO	6307	EUDAMEDFDA UDI	Class I	Active
contoured anatomical matrices	6118	EUDAMEDFDA UDI	Class I	Active
Quickmat Silicone tubes	5711	EUDAMEDFDA UDI	Class I	Active
unica minideep anterior	6911	EUDAMEDFDA UDI	Class I	Active
myTines small	6304	EUDAMEDFDA UDI	Class I	Active
SwissMat bands	41907	EUDAMED	Class I	Active
wood wedges	5015PLUS	EUDAMEDFDA UDI	Class I	Active
endo-stops	5305	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5706	EUDAMEDFDA UDI	Class I	Active
endo-stops	5306	EUDAMEDFDA UDI	Class I	Active
ID-Rings	5314	EUDAMEDFDA UDI	Class I	Active
Quickmat ring	M01339	EUDAMED	Class I	Active
SwissMat V-wedges	41908	EUDAMED	Class I	Active
3wedge	7500	EUDAMEDFDA UDI	Class I	Active
myTines refill	6310	EUDAMEDFDA UDI	Class I	Active
pinky wood wedges	5011S	EUDAMEDFDA UDI	Class I	Active
wood wedges	5012PLUS	EUDAMEDFDA UDI	Class I	Active
myRing Prime	6891	EUDAMEDFDA UDI	Class I	Active
Quickmat All-round circumferential posterior matrices	6855	EUDAMEDFDA UDI	Class I	Active
QuickmatFLEX sectional matrices	6785	EUDAMEDFDA UDI	Class I	Active
wood wedges	5002	EUDAMEDFDA UDI	Class I	Active
Roeko Polishing Strip	560030	EUDAMED	Class I	Active
QuickmatFLEX sectional matrices	6795	EUDAMEDFDA UDI	Class I	Active
ID-Rings	5318	EUDAMEDFDA UDI	Class I	Active
myTines Junior	M02012	EUDAMED	Class I	Active
myQuickmatrix forceps	5703	EUDAMEDFDA UDI	Class I	Active
Prodonto Strip abrasiva	PROCT0001M	EUDAMED	Class I	Active
Delta Silicone Tubes (Large)	S01736	EUDAMED	Class I	Active
contoured anatomical matrices	6119	EUDAMEDFDA UDI	Class I	Active
anterior dispens-O-mat	5223	EUDAMEDFDA UDI	Class I	Active
QuickmatFIT anatomical sectional matrices	5805	EUDAMEDFDA UDI	Class I	Active
Abrasive and Polishing Strips	04193	EUDAMED	Class I	Active
contoured tofflemire matrices	6108	EUDAMEDFDA UDI	Class I	Active
Strip ST	5237	EUDAMEDFDA UDI	Class I	Active
maximat plus pre-loaded	5124	EUDAMEDFDA UDI	Class I	Active
Prodonto Sistema di matrici sezionali	PROB4RINGKIT	EUDAMED	Class I	Active
stop card	5300/3	EUDAMEDFDA UDI	Class I	Active
SwissMat V-wedges	41910	EUDAMED	Class I	Active
contoured anatomical matrices	6117	EUDAMEDFDA UDI	Class I	Active
wood wedges	5012S	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5361	EUDAMEDFDA UDI	Class I	Active
Roeko Steel matrix band	590505	EUDAMED	Class I	Active
maximat plus pre-loaded	5123	EUDAMEDFDA UDI	Class I	Active
contoured anatomical matrices	6120	EUDAMEDFDA UDI	Class I	Active
wood wedges	5001PLUS	EUDAMEDFDA UDI	Class I	Active
the wedge	7015	EUDAMEDFDA UDI	Class I	Active

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