Skip to content

Cdb Clip

by Cdb Corporation

510(k) K080906

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080906 Date17 Oct 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2977-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K080906

    A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NJM
Device Class
Class II
Regulation
21 CFR Part 872.5470
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cdb Clip is an orthodontic bracket accessory classified as a ceramic orthodontic bracket component. It is designed to attach to an orthodontic bracket and secure the archwire within the bracket slot, thereby facilitating controlled tooth movement during orthodontic treatment.

The device was cleared through a traditional 510(k) submission (K080906) as substantially equivalent to a predicate device and is regulated as a Class II device under 21 CFR 872.5470. It is marketed by Cdb Corporation, located at 9201 Industrial Blvd., Leland, NC 28451, United States. The clearance indicates compliance with applicable FDA requirements for this type of orthodontic accessory.

Other devices from Cdb Corporation

See all devices from Cdb Corporation →