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Master-Dent 10-800

by Dentonics, Inc.

Master-Dent 10-800 is a device made by Dentonics, Inc., cleared under FDA 510(k) K884081 on 2 Dec 1988 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816526020169), 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) K884081

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 Number00816526020169 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK884081 Date2 Dec 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K884081 decided 2 Dec 1988 Active
  • FDA GUDID UDI-DI 00816526020169 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K884081
  2. Listed FDA GUDID 00816526020169

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  • Withdrawn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
Orthodontic bracket adhesive
Model / reference
10-800
Primary DI / UDI-DI
00816526020169
510(k) Number
GMDN term
Orthodontic bracket adhesive
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket adhesive

Cleared under the same submission (K884081)

and 8 more cleared under K884081

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)