Cleared Traditional

K912171 - PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE

K912171 is an FDA 510(k) clearance for PREDISPENSED ORTHODONTIC CERAMIC BRACKE..., manufactured by Jack James. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K912171 · Jack James · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
89d
Days
Class 1
Risk

K912171 is an FDA 510(k) clearance for the PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Jack James (Chicago, US). The FDA issued a Cleared decision on August 13, 1991 after a review of 89 days - a notably fast clearance 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: 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 Jack James devices

FDA 510(k) Submission Details - K912171

510(k) Number K912171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date August 13, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
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 47
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K912171.
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
GERMAN MINI DYNALOCK
K923432 · Unitek Corp. · Oct 1992
KLEER(TM) ORTHODONTIC BRACKET
K914616 · Ormco Corp. · Nov 1991
NONSTAINING ALASTIKS
K910288 · Unitek Corp. · Mar 1991
ENDOMETRIAL SAMPLER
K901896 · Kirwan Surgical Products, Inc. · Aug 1990
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · American Orthodontics · Aug 1990