Cleared Traditional

K973636 - MCS-MEDICATED CANAL SEALER

K973636 is an FDA 510(k) clearance for MCS-MEDICATED CANAL SEALER, manufactured by Dr. Howard Martin, P.A.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 306-day FDA review.

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

FDA 510(k) Submission Details - K973636

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
Combination Product No
PCCP Authorized No
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.

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
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K973636.
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LIQUID A
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FLOWABLE COMPOSITE
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PROVI CEMENT
K973201 · S & C Polymer GmbH · Jun 1998