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Alpha-Etch® 37 501.0103.002

by Dental Technologies, Inc.

Alpha-Etch® 37 501.0103.002 is a Class II device made by Dental Technologies, Inc., cleared under FDA 510(k) K984503 on 26 Feb 1999 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI D73550101030020), 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) K984503

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 NumberD73550101030020 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK984503 Date26 Feb 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K984503 decided 26 Feb 1999 Active
  • FDA GUDID UDI-DI D73550101030020 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K984503
  2. Listed FDA GUDID D73550101030020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alpha-Etch® 37
Generic name
Dental tooth-etching solution
Model / Ref / Catalog
501.0103.002
Primary DI / UDI-DI
D73550101030020
510(k) Number
FDA product code
KLE
GMDN term
Dental tooth-etching solution
Device class
Class II
Regulation number
872.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental etching solution

Cleared under the same submission (K984503)

and 8 more cleared under K984503

Other devices from Dental Technologies, Inc.

See all devices from Dental Technologies, Inc. →

Properties

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