Cleared Traditional

K802662 - POLYCARBONATE TEMPORARY CEMENT

K802662 is an FDA 510(k) clearance for POLYCARBONATE TEMPORARY CEMENT, manufactured by Buffalo Dental Mfg. Co., Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K802662 · Buffalo Dental Mfg. Co., Inc. · Dental device
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Dec 1980
Decision
49d
Days
Class 2
Risk

K802662 is an FDA 510(k) clearance for the POLYCARBONATE TEMPORARY CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Buffalo Dental Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 49 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 Buffalo Dental Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K802662

510(k) Number K802662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1980
Decision Date December 16, 1980
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 127d · This submission: 49d
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 434
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K802662.
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
SILICAP
K801227 · Vivadent (Usa), Inc. · Aug 1980
BONDALCAP (SILICO-PHOSPHATE)
K801228 · Vivadent (Usa), Inc. · Jun 1980
BONDALCAP (CARBOXYLATE)
K801229 · Vivadent (Usa), Inc. · Jun 1980