Cleared Traditional

K896883 - GC CERVICAL CEMENT

K896883 is an FDA 510(k) clearance for GC CERVICAL CEMENT, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K896883 · G-C Intl. Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
210d
Days
Class 2
Risk

K896883 is an FDA 510(k) clearance for the GC CERVICAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on July 6, 1990 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all G-C Intl. Corp. devices

FDA 510(k) Submission Details - K896883

510(k) Number K896883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date July 06, 1990
Days to Decision 210 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
83d slower than avg
Panel avg: 127d · This submission: 210d
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 338
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K896883.
AHYDRON DENTAL CLEANING AGENT
K902052 · Ivoclar North America, Inc. · Jul 1990
MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS
K902635 · Confi-Dental Products Co. · Jul 1990
CYANODONT DENTAL CEMENT
K901082 · Specialites Septodont · 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