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Best Etch 502225

by Vista Dental

Best Etch 502225 is a dental prosthesis priming agent (FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by Vista Dental, cleared under FDA 510(k) K984503 on 26 Feb 1999 and listed in FDA GUDID since 6 Aug 2018 (UDI-DI 10818207020151), 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 Number10818207020151 UDI-DI Date6 Aug 2018ListedStatusListed 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 10818207020151 listed 6 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K984503
  2. Listed FDA GUDID 10818207020151

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Best Etch
Generic name
Dental prosthesis priming agent
Model / reference
502225
Description
37% Phosphoric Acid Etch designed to etch and prepare dentin and enamel. Unit dose includes (30) 0.6mL prefilled syringes & (30) 22ga Pre-bent tips.
Primary DI / UDI-DI
10818207020151
510(k) Number
FDA product code
KLE
GMDN term
Dental prosthesis priming agent
Device class
Class II
Regulation number
872.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental prosthesis priming agent

Cleared under the same submission (K984503)

and 8 more cleared under K984503

Similar devices

Other devices filed under FDA product code KLE (Agent, Tooth Bonding, Resin).

Other devices from Vista Dental

See all devices from Vista Dental →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)