Cleared Traditional

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

Oct 1976
Decision
24d
Days
Class 1
Risk

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

Submitted by Parkell, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976, 24 days after receiving the submission on September 27, 1976.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3740.

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

Device Classification

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