Cleared Traditional

K902635 - MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS

K902635 is the FDA 510(k) clearance for MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS by Confi-Dental Products Co.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K902635 · Confi-Dental Products Co. · Dental device
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Jul 1990
Decision
28d
Days
Class 2
Risk

K902635 is an FDA 510(k) clearance for the MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on July 10, 1990 after a review of 28 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 Confi-Dental Products Co. devices

Submission Details

510(k) Number K902635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date July 10, 1990
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 284
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K902635.
CHEMFIL II CAPS
K901524 · Dentsply Intl. · Sep 1990
SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST
K902817 · Confi-Dental Products Co. · Aug 1990
AHYDRON DENTAL CLEANING AGENT
K902052 · Ivoclar North America, Inc. · Jul 1990
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · 3M Company · Jun 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990
GLASION
K895386 · Scientific Pharmaceuticals, Inc. · Apr 1990