Cleared Traditional

K091702 - CDB FLIP-SIDE-CLIP BRACKET

K091702 is an FDA 510(k) clearance for CDB FLIP-SIDE-CLIP BRACKET, manufactured by Cdb Corporation. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K091702 · Cdb Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
58d
Days
Class 2
Risk

K091702 is an FDA 510(k) clearance for the CDB FLIP-SIDE-CLIP BRACKET. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Cdb Corporation (Leland, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cdb Corporation devices

FDA 510(k) Submission Details - K091702

510(k) Number K091702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date August 07, 2009
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 128d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJM Device Classification - Class 2, Special Controls

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NJM Bracket, Ceramic, Orthodontic

All 57
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K091702.
CLARITY ADVANCED CERAMIC BRACKETS
K102803 · 3M Unitek Corporation · Feb 2011
ORTHODONTIC CERAMIC BRACKET
K102561 · Ht Co., Ltd. · Jan 2011
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
K101481 · Biomers Products, LLC · Jun 2010
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
K090933 · Forestadent Bernhard Forster GmbH · Jun 2009
ORTHODONTIC CERAMIC BRACKET
K090567 · Star Dentech Korea., Corp · May 2009
ALLURE MB CERAMIC BRACKETS
K090454 · Dentsply Interntional · Mar 2009