Cleared Traditional

DENTAL HANDPIECES (K760988) - FDA 510(k) Clearance

K760988 · Adp Intl., Inc. · Dental device
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Nov 1976
Decision
25d
Days
-
Risk

K760988 is an FDA 510(k) clearance for the DENTAL HANDPIECES.

Submitted by Adp Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976 after a review of 25 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 Adp Intl., Inc. devices

Submission Details

510(k) Number K760988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1976
Decision Date November 15, 1976
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 127d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -