Cleared Traditional

K823795 - EVERBOND GLASS IONOMER CEMENT

K823795 is the FDA 510(k) clearance for EVERBOND GLASS IONOMER CEMENT by Sybron Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K823795 · Sybron Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
30d
Days
Class 2
Risk

K823795 is an FDA 510(k) clearance for the EVERBOND GLASS IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sybron Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 30 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 Corp. devices

Submission Details

510(k) Number K823795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date January 26, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
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 299
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K823795.
KERR RESIN BONDED BRIDGE CEMENT
K840407 · Sybron Corp. · May 1984
GLAS IONOMER CEMENT
K841195 · Shofu Dental Corp. · May 1984
HY-BOND ZINC OXIDE EUGENOL TEMP.
K841196 · Shofu Dental Corp. · May 1984
CUTTER BOND POLYCARBOXYLATE CEMENT
K821326 · Cutter Laboratories, Inc. · May 1982
CUTTERBOND ZINC PHOSPHATE CEMENT
K813532 · Cutter Laboratories, Inc. · Mar 1982
CHEMFIL
K812858 · Dentsply Intl. · Dec 1981