Cleared Traditional

BVR CONTRA-ANGLE HANDPIECE (K934571) - FDA 510(k) Clearance

Class I Dental device.

K934571 · Bvr Aero Precision Corp. · Dental device
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Aug 1994
Decision
319d
Days
Class 1
Risk

K934571 is an FDA 510(k) clearance for the BVR CONTRA-ANGLE HANDPIECE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Bvr Aero Precision Corp. (Rockford, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bvr Aero Precision Corp. devices

Submission Details

510(k) Number K934571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1993
Decision Date August 01, 1994
Days to Decision 319 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 127d · This submission: 319d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.