Cleared Traditional

K000954 - KERR GEL ETCHANT

K000954 is an FDA 510(k) clearance for KERR GEL ETCHANT, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K000954 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
35d
Days
Class 2
Risk

K000954 is an FDA 510(k) clearance for the KERR GEL ETCHANT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on April 28, 2000 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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

FDA 510(k) Submission Details - K000954

510(k) Number K000954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2000
Decision Date April 28, 2000
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 365
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K000954.
CERAM-PRIME
K002502 · S & C Polymer GmbH · Nov 2000
MODIFICATION TO PROMPT L-POP
K001494 · Espe Dental AG · Jul 2000
PQ1
K000189 · Ultradent Products, Inc. · May 2000
BOND 1 C & B
K994359 · Jeneric/Pentron, Inc. · Mar 2000
RESIN TOOTH BONDING AGENT
K994302 · Parkell, Inc. · Feb 2000
TOKUYAMA ONE-UP-BOND F
K993917 · Tokuyama America, Inc. · Feb 2000