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Protech Glass ION.CEM.LIQ120ML 2-1210

by Ormco Corporation

Ref 740-0153, 740-0251

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889989080070 Basic UDI-DI Date18 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00889989080070 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Protech
Protech Gold
Generic Name
Glass ionomer dental cement
Device Name
Protech Glass ION.CEM.LIQ120ML 2-1210
Protech Gold Cement POWDER240G 2-1210
Model / Reference
740-0153, 740-0251
Primary DI / UDI-DI
00889989080070, 00889989075274, 00889989080018
Basic UDI-DI
B-00889989080070, B-00889989075274
510(k) Number
FDA Product Code
EMA
EMDN Code
Q0101010203 Temporary dental cements
GMDN Term
Glass ionomer dental cement
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3275
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 120 Milliliter
Weight — 240 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000038085
Authorised representative
KERR ITALIA SRL IT-AR-000007600

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No