Cleared Traditional

MCS-MEDICATED CANAL SEALER (K973636) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973636 · Dr. Howard Martin, P.A. · Dental device
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Jul 1998
Decision
306d
Days
Class 2
Risk

K973636 is an FDA 510(k) clearance for the MCS-MEDICATED CANAL SEALER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dr. Howard Martin, P.A. (Frederick, US). The FDA issued a Cleared decision on July 27, 1998 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dr. Howard Martin, P.A. devices

Submission Details

510(k) Number K973636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1997
Decision Date July 27, 1998
Days to Decision 306 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 127d · This submission: 306d
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 504
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