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Valo 4667-

by Ultradent Products, Inc.

Valo 4667- is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K132953 on 18 Feb 2014 and listed in FDA GUDID since 13 Jun 2018 (UDI-DI 00883205026040), 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) K132953

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 Number00883205026040 UDI-DI Date13 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132953 Date18 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132953 decided 18 Feb 2014 Active
  • FDA GUDID UDI-DI 00883205026040 listed 13 Jun 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132953
  2. Listed FDA GUDID 00883205026040

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Valo
Generic name
Medical equipment handle cover, single-use, non-sterile
Model / Ref / Catalog
4667-
Primary DI / UDI-DI
00883205026040
510(k) Number
FDA product code
PEM
GMDN term
Medical equipment handle cover, single-use, non-sterile
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical equipment handle cover, single-use, non-sterile

Cleared under the same submission (K132953)

and 7 more cleared under K132953

Similar devices

Other devices filed under FDA product code PEM (Dental barriers and sleeves).

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

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