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Zr-P Bottle 90577

by Vista Dental

Zr-P Bottle 90577 is a Class II device made by Vista Dental, cleared under FDA 510(k) K131049 on 27 Aug 2013 and listed in FDA GUDID since 4 Jun 2026 (UDI-DI 00850194007763), 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) K131049

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 Number00850194007763 UDI-DI Date4 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131049 Date27 Aug 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131049 decided 27 Aug 2013 Active
  • FDA GUDID UDI-DI 00850194007763 listed 4 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131049
  2. Listed FDA GUDID 00850194007763

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Zr-P Bottle
Generic name
Dental prosthesis-component adhesive
Model / reference
90577
Primary DI / UDI-DI
00850194007763
510(k) Number
FDA product code
KLE
GMDN term
Dental prosthesis-component adhesive
Device class
Class II
Regulation number
872.3200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K131049)

Other devices from Vista Dental

See all devices from Vista Dental →

Properties

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