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Trinia 260-612-120

by Bicon, LLC

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 22 Oct 2026

Documents

510(k) K133608

FDA submission, from GUDID

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813110020093 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK133608 Date14 Mar 2014IssuedStatusActive

Official records

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trinia
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
260-612-120
Primary DI / UDI-DI
00813110020093
510(k) Number
FDA product code
EBI, EBG, EBF
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3760, 872.3770, 872.3690
GUDID distribution status
In Commercial Distribution

Other devices from Bicon, LLC

See all devices from Bicon, LLC →

Properties

  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No