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Estelite Sigma Quick 13119

by Tokuyama Dental Corporation

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) K080940

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04548190131198 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080940 Date19 Jun 2008DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
Estelite Sigma Quick
Generic name
Dental composite resin
Model / reference
13119
Primary DI / UDI-DI
04548190131198
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K080940)

Show all (12)

Other devices from Tokuyama Dental Corporation

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (12)

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