Cleared Traditional

IMPULSE HEAT SEALER (K760121) - FDA 510(k) Clearance

K760121 · Lorvic Corp. · Dental device
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Jul 1976
Decision
18d
Days
-
Risk

K760121 is an FDA 510(k) clearance for the IMPULSE HEAT SEALER.

Submitted by Lorvic Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1976 after a review of 18 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 Lorvic Corp. devices

Submission Details

510(k) Number K760121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1976
Decision Date July 16, 1976
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -