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Master-Dent 12-675

by Dentonics, Inc.

Master-Dent 12-675 is a device made by Dentonics, Inc., cleared under FDA 510(k) K933543 on 1 Nov 1993 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816526021227), active as of 22 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 22 Oct 2026

Documents

510(k) K933543

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816526021227 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK933543 Date1 Nov 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K933543 decided 1 Nov 1993 Active
  • FDA GUDID UDI-DI 00816526021227 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K933543
  2. Listed FDA GUDID 00816526021227

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Master-Dent
Generic name
Endodontic filling/sealing material
Model / Ref / Catalog
12-675
Primary DI / UDI-DI
00816526021227
510(k) Number
GMDN term
Endodontic filling/sealing material
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endodontic filling/sealing material

Cleared under the same submission (K933543)

and 2 more cleared under K933543

Other devices from Dentonics, Inc.

See all devices from Dentonics, Inc. →

Properties

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