Cleared Traditional

SR-IVOSEAL(SOFT RELINING) (K810656) - FDA 510(k) Clearance

K810656 · J. Aderer, Inc. · Dental device
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Apr 1981
Decision
47d
Days
-
Risk

K810656 is an FDA 510(k) clearance for the SR-IVOSEAL(SOFT RELINING).

Submitted by J. Aderer, Inc. (Walker, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 J. Aderer, Inc. devices

Submission Details

510(k) Number K810656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1981
Decision Date April 14, 1981
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -