Cleared Traditional

SAFE-T-PINS RETENTIVE PIN SYSTEM (K760723) - FDA 510(k) Clearance

Class I Dental device.

K760723 · Parkell, Inc. · Dental device
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Oct 1976
Decision
24d
Days
Class 1
Risk

K760723 is an FDA 510(k) clearance for the SAFE-T-PINS RETENTIVE PIN SYSTEM. Classified as Pin, Retentive And Splinting, And Accessory Instruments (product code EBL), Class I - General Controls.

Submitted by Parkell, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3740 - 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: 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 Parkell, Inc. devices

Submission Details

510(k) Number K760723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1976
Decision Date October 21, 1976
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBL Pin, Retentive And Splinting, And Accessory Instruments
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3740
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.