Cleared Traditional

K812115 - KETAC-CHEM

K812115 is an FDA 510(k) clearance for KETAC-CHEM, manufactured by Espe-Premier Sales Co.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K812115 · Espe-Premier Sales Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
35d
Days
Class 2
Risk

K812115 is an FDA 510(k) clearance for the KETAC-CHEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe-Premier Sales Co. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Espe-Premier Sales Co. devices

FDA 510(k) Submission Details - K812115

510(k) Number K812115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1981
Decision Date August 31, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 439
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K812115.
CUTTERBOND ZINC PHOSPHATE CEMENT
K813532 · Cutter Laboratories, Inc. · Mar 1982
CHEMFIL
K812858 · Dentsply Intl. · Dec 1981
CAVITRON
K812568 · G-C Intl. Corp. · Sep 1981
FUJI IONOMER TYPE I & II
K811521 · G-C Intl. Corp. · Jun 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · Shofu Dental Corp. · Jun 1981
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · Shofu Dental Corp. · Jun 1981