Cleared Traditional

K913572 - AUTOPACK NON-EUGENOL PERIODONTAL DRESSING

K913572 is an FDA 510(k) clearance for AUTOPACK NON-EUGENOL PERIODONTAL DRESSING, manufactured by Specialites Septodont. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K913572 · Specialites Septodont · Dental device
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Oct 1991
Decision
58d
Days
Class 2
Risk

K913572 is an FDA 510(k) clearance for the AUTOPACK NON-EUGENOL PERIODONTAL DRESSING. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 58 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 Specialites Septodont devices

FDA 510(k) Submission Details - K913572

510(k) Number K913572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date October 09, 1991
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
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.