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Acid Etchant 020-028535

by American Orthodontics

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190746134753 UDI-DI Date21 May 2019ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Acid Etchant
Generic Name
Dental tooth-etching solution
Model / Ref / Catalog
020-028535
Primary DI / UDI-DI
00190746134753
510(k) Number
FDA Product Code
KLE
GMDN Term
Dental tooth-etching solution
Device Class
Class II
Regulation Number
872.3200
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K872569)

Show all (12)

Other devices from American Orthodontics

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No