Cleared Traditional

K893037 - NO-MIX 30 ORTHODONTIC BONDING SYSTEMS

K893037 is the FDA 510(k) clearance for NO-MIX 30 ORTHODONTIC BONDING SYSTEMS by American Orthodontics. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K893037 · American Orthodontics · Dental device
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Jun 1989
Decision
49d
Days
Class 2
Risk

K893037 is an FDA 510(k) clearance for the NO-MIX 30 ORTHODONTIC BONDING SYSTEMS. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 K893037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date June 12, 1989
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 81
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K893037.
FORCE II
K895163 · American Orthodontics · Oct 1989
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
K893396 · American Orthodontics · Jun 1989
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
K893255 · American Orthodontics · Jun 1989
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · Scientific Pharmaceuticals, Inc. · May 1989
FRS LITE FLUORIDE RELEASING SEALANT
K890740 · Ormco Corp. · Apr 1989
ORTHO-SEAL
K883465 · Bisco, Inc. · Oct 1988