Cleared Traditional

K943644 - IMPLANTECH TEMPORAL IMPLANT

K943644 is the FDA 510(k) clearance for IMPLANTECH TEMPORAL IMPLANT by Implantech Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FWP) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K943644 · Implantech Associates, Inc. · General & Plastic Surgery device
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Oct 1994
Decision
83d
Days
Class 2
Risk

K943644 is an FDA 510(k) clearance for the IMPLANTECH TEMPORAL IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Van Nuys, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - the FDA general and plastic surgery device 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 Implantech Associates, Inc. devices

Submission Details

510(k) Number K943644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 27, 1994
Decision Date October 18, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FWP Prosthesis, Chin, Internal

All 11
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