Cleared Traditional

K972890 - ENLIGHT (TENTATIVE NAME)

K972890 is the FDA 510(k) clearance for ENLIGHT (TENTATIVE NAME) by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K972890 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
42d
Days
Class 2
Risk

K972890 is an FDA 510(k) clearance for the ENLIGHT (TENTATIVE NAME). Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 16, 1997 after a review of 42 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K972890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1997
Decision Date September 16, 1997
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 72
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K972890.
ENLIGHT LV
K984362 · Sybron Dental Specialties, Inc. · Jan 1999
ENLIGHT-2
K984217 · Sybron Dental Specialties, Inc. · Jan 1999
GC FUJI ORTHO LC
K981461 · GC America, Inc. · Jun 1998
ORTHO-ONE
K962946 · Bisco, Inc. · Sep 1996
GC FUJI ORTHO
K961417 · GC America, Inc. · May 1996
PULPDENT TOUCHDOWN
K953217 · Pulpdent Corp. · Aug 1995