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Total C-Ram Translucent

by Itena Clinical

Ref TTCRAM-TR

Total C-Ram Translucent (TTCRAM-TR) is a device classified as Class IIa in the EU and Class II in the US made by Itena Clinical, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI B-03760260221061), cleared under FDA 510(k) K162960 on 14 Mar 2017 and listed in FDA GUDID since 11 Jun 2017 (UDI-DI 03760260221061), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162960

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760260221061 Basic UDI-DI 03760260221061UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760260221061 UDI-DI Date11 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK162960 Date14 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760260221061 registered 25 Jun 2026 Active
  • FDA 510(k) K162960 decided 14 Mar 2017 Active
  • FDA GUDID UDI-DI 03760260221061 listed 11 Jun 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162960
  2. Listed FDA GUDID 03760260221061
  3. Registered EUDAMED B-03760260221061

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Total C-Ram
Generic name
Dental composite resin
Model / Ref / Catalog
TTCRAM-TR, TRANSLUCENT
Primary DI / UDI-DI
03760260221061
Basic UDI-DI
B-03760260221061
510(k) Number
FDA product code
EMA
EMDN code
Q0101010299 Temporary and permanent dental restoration cements - other
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TTCRAM-TR
GUDID
TRANSLUCENT
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

Cleared under the same submission (K162960)

Similar devices in this category

Other devices filed under TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER.

Other devices from Itena Clinical

See all devices from Itena Clinical →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)