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Total C-Ram Translucent

by Itena Clinical

Total C-Ram Translucent (ECHTCRAM) is a Class II device made by Itena Clinical, cleared under FDA 510(k) K162960 on 14 Mar 2017 and listed in FDA GUDID since 31 Oct 2017 (UDI-DI 03760260221207), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K162960

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760260221207 UDI-DI Date31 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK162960 Date14 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162960 decided 14 Mar 2017 Active
  • FDA GUDID UDI-DI 03760260221207 listed 31 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162960
  2. Listed FDA GUDID 03760260221207

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Total C-Ram
Generic name
Dental composite resin
Model / Ref / Catalog
TRANSLUCENT, ECHTCRAM
Primary DI / UDI-DI
03760260221207
510(k) Number
FDA product code
EMA
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K162960)

Similar devices in this category

Other devices filed under Dental composite resin.

Other devices from Itena Clinical

See all devices from Itena Clinical →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)