Cleared Traditional

K090933 - BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS

K090933 is an FDA 510(k) clearance for BERNHARD-FORSTER GMBH ORTHODONTIC CERAM..., manufactured by Forestadent Bernhard Forster GmbH. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K090933 · Forestadent Bernhard Forster GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
64d
Days
Class 2
Risk

K090933 is an FDA 510(k) clearance for the BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Forestadent Bernhard Forster GmbH (Pforzheim, Baden Wurtemberg, DE). The FDA issued a Cleared decision on June 5, 2009 after a review of 64 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.

FDA 510(k) Submission Details - K090933

510(k) Number K090933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2009
Decision Date June 05, 2009
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
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 59
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K090933.
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K090933 · BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
Download PDF FDA Summary Forestadent Bernhard …