Cleared Traditional

RIGHT-ON ADHESIVE BOUDING SYSTEM (K952643) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952643 · Tp Orthodontics, Inc. · Dental device
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Jul 1995
Decision
32d
Days
Class 2
Risk

K952643 is an FDA 510(k) clearance for the RIGHT-ON ADHESIVE BOUDING SYSTEM. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 32 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 Tp Orthodontics, Inc. devices

Submission Details

510(k) Number K952643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date July 11, 1995
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
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 29
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K952643.
GC FUJI ORTHO BAND PASTE PAK
K020578 · GC America, Inc. · Apr 2002
GC FUJI ORTHO LC
K981461 · GC America, Inc. · Jun 1998
GC FUJI ORTHO
K961417 · GC America, Inc. · May 1996
FUJI ORTHO LC
K950556 · GC America, Inc. · Mar 1995
ACCLAIM* BRACKET ADHESIVE
K864008 · Johnson & Johnson Professionals, Inc. · Oct 1986
EXCEL BRACKET ADHESIVE
K854050 · Johnson & Johnson Professionals, Inc. · Nov 1985