Cleared Traditional

BOSWORTH WOODEN WEDGES (K820892) - FDA 510(k) Clearance

K820892 · Harry J. Bosworth Co. · Dental device
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May 1982
Decision
36d
Days
-
Risk

K820892 is an FDA 510(k) clearance for the BOSWORTH WOODEN WEDGES.

Submitted by Harry J. Bosworth Co. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K820892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date May 05, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -