Cleared Traditional

METALIT (K790807) - FDA 510(k) Clearance

Class I Dental device.

K790807 · Harry J. Bosworth Co. · Dental device
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Aug 1979
Decision
101d
Days
Class 1
Risk

K790807 is an FDA 510(k) clearance for the METALIT. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Harry J. Bosworth Co. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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. Standard predicate reliance. 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K790807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date August 03, 1979
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBA Light, Surgical Headlight
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.