Cleared Traditional

K984217 - ENLIGHT-2

K984217 is the FDA 510(k) clearance for ENLIGHT-2 by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K984217 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
57d
Days
Class 2
Risk

K984217 is an FDA 510(k) clearance for the ENLIGHT-2. 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 January 20, 1999 after a review of 57 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 K984217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date January 20, 1999
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 K984217.
SOLO ORTHO
K990743 · Sybron Dental Specialties, Inc. · Jun 1999
SOLO PLUS ORTHO
K990252 · Sybron Dental Specialties, Inc. · Feb 1999
ENLIGHT LV
K984362 · 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
ORTHO-ONE
K962946 · Bisco, Inc. · Sep 1996