Cleared Traditional

K974458 - COMPOLUTE APLICAP

K974458 is an FDA 510(k) clearance for COMPOLUTE APLICAP, manufactured by Espe Dental-Medizin GmbH & Co.Kg.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K974458 · Espe Dental-Medizin GmbH & Co.Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
69d
Days
Class 2
Risk

K974458 is an FDA 510(k) clearance for the COMPOLUTE APLICAP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe Dental-Medizin GmbH & Co.Kg. (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on February 2, 1998 after a review of 69 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 Dental-Medizin GmbH & Co.Kg. devices

FDA 510(k) Submission Details - K974458

510(k) Number K974458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1997
Decision Date February 02, 1998
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
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 386
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