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Master-Dent 12-104

by Dentonics, Inc.

Master-Dent 12-104 is a device made by Dentonics, Inc., cleared under FDA 510(k) K843098 on 7 Sep 1984 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816526020282), 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) K843098

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 Number00816526020282 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK843098 Date7 Sep 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K843098 decided 7 Sep 1984 Active
  • FDA GUDID UDI-DI 00816526020282 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K843098
  2. Listed FDA GUDID 00816526020282

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  • Withdrawn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
Dental pit/fissure sealant
Model / reference
12-104
Primary DI / UDI-DI
00816526020282
510(k) Number
GMDN term
Dental pit/fissure sealant
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental pit/fissure sealant

Cleared under the same submission (K843098)

and 1 more cleared under K843098

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)