Cleared Traditional

K843527 - ORTHOMITE 111 ADHESIVE

K843527 is the FDA 510(k) clearance for ORTHOMITE 111 ADHESIVE by Rocky Mountain Orthodontics, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K843527 · Rocky Mountain Orthodontics, Inc. · Dental device
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Oct 1984
Decision
41d
Days
Class 2
Risk

K843527 is an FDA 510(k) clearance for the ORTHOMITE 111 ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Rocky Mountain Orthodontics, Inc. (Denver, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 41 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 Rocky Mountain Orthodontics, Inc. devices

Submission Details

510(k) Number K843527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date October 18, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 127d · This submission: 41d
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 121
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K843527.
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · Dentsply Intl. · Nov 1985
CLEANSE N BOND I
K844133 · Lee Pharmaceuticals · Jan 1985
CLEANSE N BOND II
K844134 · Lee Pharmaceuticals · Jan 1985
BOSWORTH SUPER BOND DENTAL ADHESIVE
K842448 · Harry J. Bosworth Co. · Sep 1984
SOLO-TACH
K832292 · Dentsply Intl. · Sep 1983
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
K832112 · Scientific Pharmaceuticals, Inc. · Aug 1983