Cleared Traditional

K962946 - ORTHO-ONE

K962946 is the FDA 510(k) clearance for ORTHO-ONE by Bisco, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K962946 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
36d
Days
Class 2
Risk

K962946 is an FDA 510(k) clearance for the ORTHO-ONE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on September 3, 1996 after a review of 36 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 Bisco, Inc. devices

Submission Details

510(k) Number K962946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1996
Decision Date September 03, 1996
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
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 K962946.
ENLIGHT-2
K984217 · Sybron Dental Specialties, Inc. · Jan 1999
GC FUJI ORTHO LC
K981461 · GC America, Inc. · Jun 1998
ENLIGHT (TENTATIVE NAME)
K972890 · Sybron Dental Specialties, Inc. · Sep 1997
GC FUJI ORTHO
K961417 · GC America, Inc. · May 1996
PULPDENT TOUCHDOWN
K953217 · Pulpdent Corp. · Aug 1995
PULPDENT GLASS IONOMER CEMENTS
K952854 · Pulpdent Corp. · Jul 1995