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Master-Dent 20-228

by Dentonics, Inc.

Master-Dent 20-228 is a Class II device made by Dentonics, Inc., cleared under FDA 510(k) K930248 on 7 Jan 1994 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816526021746), 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) K930248

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 Number00816526021746 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK930248 Date7 Jan 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K930248 decided 7 Jan 1994 Active
  • FDA GUDID UDI-DI 00816526021746 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K930248
  2. Listed FDA GUDID 00816526021746

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  • Withdrawn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 impression material syringe, reusable
Model / reference
20-228
Primary DI / UDI-DI
00816526021746
510(k) Number
FDA product code
ELW
GMDN term
Dental impression material syringe, reusable
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental impression material syringe, reusable

Cleared under the same submission (K930248)

and 8 more cleared under K930248

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)