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Dental City 25-2052BL

by Icp, Inc.

Dental City 25-2052BL is a Class II device made by Icp, Inc., cleared under FDA 510(k) K133070 on 22 Jun 2015 and listed in FDA GUDID since 21 May 2026 (UDI-DI D771252052BL1), 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) K133070

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 NumberD771252052BL1 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133070 Date22 Jun 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133070 decided 22 Jun 2015 Active
  • FDA GUDID UDI-DI D771252052BL1 listed 21 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133070
  2. Listed FDA GUDID D771252052BL1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dental City
Generic name
Surgical/medical respirator, non-antimicrobial, single-use
Model / reference
25-2052BL
Primary DI / UDI-DI
D771252052BL1
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical respirator, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K133070)

and 8 more cleared under K133070

Other devices from Icp, Inc.

See all devices from Icp, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)