Cleared Traditional

K954643 - TRY-IN GEL

K954643 is the FDA 510(k) clearance for TRY-IN GEL by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K954643 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
9d
Days
Class 2
Risk

K954643 is an FDA 510(k) clearance for the TRY-IN GEL. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 K954643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date October 19, 1995
Days to Decision 9 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
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 233
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K954643.
OPTIBOND 2A PRECOAT
K955068 · Sybron Dental Specialties, Inc. · Dec 1995
PULPDENT RESILUTE
K955017 · Pulpdent Corp. · Dec 1995
NEXUS
K954762 · Sybron Dental Specialties, Inc. · Nov 1995
PULPDENT DENTASTIC II
K953272 · Pulpdent Corp. · Aug 1995
DENTASTIC ONE-STEP
K953301 · Pulpdent Corp. · Aug 1995
PULPDENT POST CEMENT
K952960 · Pulpdent Corp. · Jul 1995