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Estelite Sigma Quick

by Tokuyama Dental Corporation

510(k) K080940

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04548190133918 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK080940 Date19 Jun 2008ClearedStatusActive

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  • Withdrawn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

510(k) · GUDID

Generic name
Dental composite resin
Model / reference
13391
Primary DI / UDI-DI
04548190133918
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before 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