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Master-Dent 19-412-A2

by Dentonics, Inc.

Master-Dent 19-412-A2 is a device made by Dentonics, Inc., cleared under FDA 510(k) K833810 on 21 Feb 1984 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816526021487), 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) K833810

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 Number00816526021487 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK833810 Date21 Feb 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K833810 decided 21 Feb 1984 Active
  • FDA GUDID UDI-DI 00816526021487 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K833810
  2. Listed FDA GUDID 00816526021487

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  • Withdrawn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 composite resin
Model / reference
19-412-A2
Primary DI / UDI-DI
00816526021487
510(k) Number
GMDN term
Dental composite resin
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K833810)

and 8 more cleared under K833810

Similar devices in this category

Other devices filed under Dental composite resin.

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)