Cleared Traditional

K921580 - BRINK PRE-MAXILLARY IMPLANT

K921580 is an FDA 510(k) clearance for BRINK PRE-MAXILLARY IMPLANT, manufactured by Implantech Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K921580 · Implantech Associates, Inc. · General & Plastic Surgery device
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May 1992
Decision
34d
Days
Class 2
Risk

K921580 is an FDA 510(k) clearance for the BRINK PRE-MAXILLARY IMPLANT. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on May 6, 1992 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - 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

FDA 510(k) Submission Details - K921580

510(k) Number K921580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date May 06, 1992
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 - FZE Prosthesis, Nose, Internal

All 23
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K921580.
IMPLANTECH DORSAL NASAL IMPLANT
K942876 · Implantech Associates, Inc. · Jul 1994
NASAL DORSUM
K925743 · Smith & Nephew Richards, Inc. · Aug 1993
RIZZO NASAL IMPLANT
K925426 · Implantech Associates, Inc. · May 1993
FLOWERS NASAL IMPLANT
K904656 · Implantech Associates, Inc. · Dec 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657 · Implantech Associates, Inc. · Dec 1990
SILASTIC NASAL IMPLANT S-TYPE
K880405 · Dow Corning Wright · Feb 1988