Cleared Traditional

K897188 - KETAC-CEM MAXICAP

K897188 is the FDA 510(k) clearance for KETAC-CEM MAXICAP by Espe GmbH (Us). It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K897188 · Espe GmbH (Us) · Dental device
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Mar 1990
Decision
89d
Days
Class 2
Risk

K897188 is an FDA 510(k) clearance for the KETAC-CEM MAXICAP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 89 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 GmbH (Us) devices

Submission Details

510(k) Number K897188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1989
Decision Date March 27, 1990
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 292
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K897188.
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990
GLASION
K895386 · Scientific Pharmaceuticals, Inc. · Apr 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · Confi-Dental Products Co. · Feb 1990
GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
K894953 · Confi-Dental Products Co. · Feb 1990
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990