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Master-Dent 10-304

by Dentonics, Inc.

Master-Dent 10-304 is a device made by Dentonics, Inc., cleared under FDA 510(k) K933612 on 24 Feb 1994 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816526020152), 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) K933612

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 Number00816526020152 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK933612 Date24 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K933612 decided 24 Feb 1994 Active
  • FDA GUDID UDI-DI 00816526020152 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K933612
  2. Listed FDA GUDID 00816526020152

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  • Withdrawn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
Zinc polycarboxylate dental cement
Model / reference
10-304
Primary DI / UDI-DI
00816526020152
510(k) Number
GMDN term
Zinc polycarboxylate dental cement
GUDID distribution status
In Commercial Distribution

Related devices

Category: Zinc polycarboxylate dental cement

Cleared under the same submission (K933612)

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)