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Maximat plus kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 5190

by Polydentia SA

Identity

Trade Name
Maximat plus kit EUDAMEDFDA UDI
Generic Name
Dental matrix band kit FDA UDI
Device Name
Maximat Plus kit EUDAMED
Model / Reference
5190 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
+E29951900 EUDAMED
E29951900 FDA UDI
Basic UDI-DI
++E299MPIVG EUDAMED
FDA Product Code
DZN FDA UDI
EMDN Code
Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
GMDN Term
Dental matrix band kit FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.4565 FDA UDI
Medical Purpose
Circumferential matrices for posterior dental restorations EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Maximat plus kit by Polydentia SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polydentia SA
EUDAMED SRN
CH-PR-000009114

Sources (2)

  • EUDAMED 20e784e6-a6a1-4163-82ed-cd183b2d90fb 61 fields · synced May 31, 2026
  • FDA UDI e985f632-b152-486c-a8ba-063a90bf4550 32 fields · synced May 29, 2026