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Master-Dent 20-701

by Dentonics, Inc.

Master-Dent 20-701 is a device made by Dentonics, Inc., cleared under FDA 510(k) K041028 on 14 May 2004 and listed in FDA GUDID since 19 Dec 2016 (UDI-DI 00816526021944), 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) K041028

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 Number00816526021944 UDI-DI Date19 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041028 Date14 May 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041028 decided 14 May 2004 Active
  • FDA GUDID UDI-DI 00816526021944 listed 19 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K041028
  2. Listed FDA GUDID 00816526021944

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  • Withdrawn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
20-701
Description
Vinyl Polysiloxane Cartridges, Refill Kit , FAST Set, Monophase, 2 X 380 ml cartridge
Primary DI / UDI-DI
00816526021944
510(k) Number
GMDN term
Dental impression material syringe, reusable
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental impression material syringe, reusable

Cleared under the same submission (K041028)

and 8 more cleared under K041028

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)