Cleared Traditional

K770090 - BLACHLY BITE BLOK & CHEEK FILLER

K770090 is an FDA 510(k) clearance for BLACHLY BITE BLOK & CHEEK FILLER, manufactured by P.H. Blachly, M.D.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K770090 · P.H. Blachly, M.D. · Neurology device
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Jan 1977
Decision
14d
Days
Class 2
Risk

K770090 is an FDA 510(k) clearance for the BLACHLY BITE BLOK & CHEEK FILLER. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by P.H. Blachly, M.D. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1977 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - the FDA neurology 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.

FDA 510(k) Submission Details - K770090

510(k) Number K770090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1977
Decision Date January 31, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 149d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXL Device Classification - Class 2, Special Controls

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
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 Neurology devices follow this clearance model.

K770090 · BLACHLY BITE BLOK & CHEEK FILLER
Download PDF P.H. Blachly, M.D.