Skip to content

Essential Dustless alginate 1127284

by Henry Schein, Inc.

Essential Dustless alginate 1127284 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K011785 on 4 Sep 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040018705), active as of 23 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 23 Oct 2026

Documents

510(k) K011785

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00304040018705 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011785 Date4 Sep 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011785 decided 4 Sep 2001 Active
  • FDA GUDID UDI-DI 00304040018705 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011785
  2. Listed FDA GUDID 00304040018705

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Essential Dustless alginate
Generic name
Alginate dental impression material
Model / Ref / Catalog
1127284
Primary DI / UDI-DI
00304040018705
510(k) Number
FDA product code
ELW
GMDN term
Alginate dental impression material
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Alginate dental impression material

Cleared under the same submission (K011785)

and 8 more cleared under K011785

Similar devices

Other devices filed under FDA product code ELW (MATERIAL, IMPRESSION).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)