Cleared Traditional

K891775 - MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES

K891775 is the FDA 510(k) clearance for MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES by American Orthodontics. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K891775 · American Orthodontics · Dental device
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May 1989
Decision
48d
Days
Class 1
Risk

K891775 is an FDA 510(k) clearance for the MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 48 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 American Orthodontics devices

Submission Details

510(k) Number K891775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date May 11, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 30
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K891775.
X-RING SEPARATORS
K893549 · American Orthodontics · Jun 1989
MEMORY CHAIN
K893654 · American Orthodontics · Jun 1989
GEM II ORTHODONTIC BRACKET
K892704 · Ormco Corp. · Jun 1989
FILAFLEX ORTHODONTIC WIRE
K891599 · American Orthodontics · May 1989
JASPER JUMPER KIT
K890536 · American Orthodontics · May 1989
LIP BUMPER
K890656 · American Orthodontics · Apr 1989