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ClearVu Mini Readi-Base Bracket 297-103CVX

by Tp Orthodontics, Inc.

ClearVu Mini Readi-Base Bracket 297-103CVX is a Class II device made by Tp Orthodontics, Inc., cleared under FDA 510(k) K950992 on 3 May 1995 and listed in FDA GUDID since 22 Feb 2019 (UDI-DI 00192029000632), 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) K950992

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 Number00192029000632 UDI-DI Date22 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK950992 Date3 May 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K950992 decided 3 May 1995 Active
  • FDA GUDID UDI-DI 00192029000632 listed 22 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K950992
  2. Listed FDA GUDID 00192029000632

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ClearVu Mini Readi-Base Bracket
Generic name
Orthodontic bracket, ceramic
Model / reference
297-103CVX
Description
Upper & Lower 3-3 Cuspid with Hooks 0.56 mm (.022")
Primary DI / UDI-DI
00192029000632
510(k) Number
FDA product code
NJM
GMDN term
Orthodontic bracket, ceramic
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Other devices from Tp Orthodontics, Inc.

See all devices from Tp Orthodontics, Inc. →

Properties

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