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
myQuickmat Hoop kit	6600	EUDAMED	Class I	Active
Fiber-Plast 1x48ml + 12 Cannule	5974	FDA UDI	Class II	Active
Fiber-Bond 1x3ml	5973	FDA UDI	Class II	Active
Fiber-Splint ML Mini Starter Kit	5976	FDA UDI	Class II	Active
Fiber-Plast 2x48ml + 12 Cannule	5974	FDA UDI	Class II	Active
Hemo-wedge	5022	FDA UDI	Class I	Active
Fiber-Bond 2x3ml	5973	FDA UDI	Class II	Active
Fiber-bond 2x5ml	6525	FDA UDI	Class II	Active
Hemo-wedge	5020	FDA UDI	Class I	Active
Polydentia matrix system trial kit	2103	FDA UDI	Class I	Unknown
Hemo-wedge	5024	FDA UDI	Class I	Active
Hemo-wedge	5023	FDA UDI	Class I	Active
Fiber-bond 1x5ml	6525	FDA UDI	Class II	Active
Hemo-wedge	5025	FDA UDI	Class I	Active
Macro-Wedges	5030	FDA UDI	Class I	Active
Hemo-wedge	5021	FDA UDI	Class I	Active
anatomic superthin matrices	5715	EUDAMEDFDA UDI	Class I	Active
Re-Force	M01682	EUDAMED	Class I	Active
Quickmat sectional matrices	5746	EUDAMEDFDA UDI	Class I	Active
Quickmat sectional matrices	5705	EUDAMEDFDA UDI	Class I	Active
F-Splint-Aid	5972	EUDAMEDFDA UDI	Class IIa	Active
3wedge	7503	EUDAMEDFDA UDI	Class I	Active
F-Splint-Aid & Slim	5980	EUDAMEDFDA UDI	Class IIa	Active
Unica proximal	1201	EUDAMED	Class I	Active
siqveland matrices	5725	EUDAMEDFDA UDI	Class I	Active
Maxi ID-Rings	5370	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6766	EUDAMEDFDA UDI	Class I	Active
Kent Dental Interdental Wedges	3134152	EUDAMED	Class I	Active
myRing Junior	S01761	EUDAMED	Class I	Active
Strip 0.05	5255	EUDAMEDFDA UDI	Class I	Active
clearmat transparent matrices	5913	EUDAMEDFDA UDI	Class I	Active
diamond24	6312	EUDAMEDFDA UDI	Class I	Active
orange wood wedges	5018PLUS	EUDAMEDFDA UDI	Class I	Active
the wedge	7012	EUDAMEDFDA UDI	Class I	Active
QuickmatFLEX sectional matrices	6797	EUDAMEDFDA UDI	Class I	Active
Simplee Molar Sectional Matrix Bands	156123	EUDAMED	Class I	Active
Precimatrix Cunei Legno	PR0MATCL15	EUDAMED	Class I	Active
unica minideep anterior	6951	EUDAMEDFDA UDI	Class I	Active
Prodonto Matrici sezionali	PROB45705	EUDAMED	Class I	Active
tofflemire transparent matrices	5936	EUDAMEDFDA UDI	Class I	Active
Lumicontrast sectional matrices	6736	EUDAMEDFDA UDI	Class I	Active
Unica Anterior	S01748	EUDAMED	Class I	Active
Strip 0.05	5257	EUDAMEDFDA UDI	Class I	Active
Lumicontrast anterior strip	S01768	EUDAMED	Class I	Active
Maximat plus kit	5190	EUDAMEDFDA UDI	Class I	Active
orange wood wedges	5018	EUDAMEDFDA UDI	Class I	Active
Quickmat quickrings	5710	EUDAMEDFDA UDI	Class I	Active
tofflemire transparent matrices	5916	EUDAMEDFDA UDI	Class I	Active
the wedge	7040	EUDAMEDFDA UDI	Class I	Active
wood wedges	5011PLUS	EUDAMEDFDA UDI	Class I	Active

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