Cleared Traditional

K924971 - FORESTADENT BRACKETS

K924971 is an FDA 510(k) clearance for FORESTADENT BRACKETS, manufactured by Forestadent Bernhard Forster GmbH. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K924971 · Forestadent Bernhard Forster GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
239d
Days
Class 1
Risk

K924971 is an FDA 510(k) clearance for the FORESTADENT BRACKETS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Forestadent Bernhard Forster GmbH (D-7530 Pforzheim Germany, GR). The FDA issued a Cleared decision on May 27, 1993 after a review of 239 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K924971

510(k) Number K924971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date May 27, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 128d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 95
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K924971.
ION-IMPLANTED NEO SENTALLOY
K932025 · Gac Intl., Inc. · Sep 1993
SOLO TIES
K930452 · Zulaf, Inc. · Jul 1993
NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
K931663 · Ortho Organizers, Inc. · Jul 1993
THE HERBST APPLIANCE
K923405 · Ormco Corp. · May 1993
APEX DIRECT BONDED BRACKETS
K923440 · Apex Orthodontics, Inc. · Mar 1993
MEMORY WIRE
K923709 · Wire Products · Feb 1993
K924971 · FORESTADENT BRACKETS
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