Safe-T-Pins Retentive Pin System

FDA 510(k) K760723 · Parkell, Inc.

Substantially Equivalent

510(k) numberK760723

Submission

Device name
Safe-T-Pins Retentive Pin System
Applicant
Parkell, Inc.
Mchenry, IL, US
Received
September 27, 1976
Decision date
October 21, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EBL – Pin, Retentive And Splinting, And Accessory Instruments
Device class
Class I (low risk)
Regulation
21 CFR 872.3740
Specialty
Dental

Other 510(k)s with product code EBL

510(k)DeviceApplicantDecision
K002693CBW Bridge System (Consisting of CBW Andchors, CBW Micro-Handpiece and Burs)EBL · Traditional Cbs Intl. B.V.11/09/2000SE
K952868Dentaurum Jacket Crown & Root PostsEBL · Traditional Dentauraum, Inc.07/19/1995SE
K924376Root Canal PostEBL · Traditional The Thera Group11/22/1993SE
K895283Prosthetic Restoration DeviceEBL · Traditional Swiss Precision Mfg. Corp.02/14/1990SE
K895758Plastic Tooth Reinforcement KitEBL · Traditional Nanzee Dental Products12/20/1989SE
K883074ElgiloyEBL · Traditional Dale T. Dupuis08/09/1988SE
K863831Vivadent FilpinEBL · Traditional Vivadent (Usa), Inc.10/14/1986SE
K844457SecuripinEBL · Traditional Hughes Int'L, Inc.12/27/1984SE
K830773Markley Threaded WireEBL · Traditional Almore Intl., Inc.04/28/1983SE
K822412Reinforcing PinEBL · Traditional Filhol08/30/1982SE

More from Filhol

510(k)DeviceDecision
K243254Parkell Pit and Fissure SealantEBC · Abbreviated 08/08/2025SE
K210259Parkell Self-Adhesive CementEMA · Traditional 01/20/2022SE
K191103Parkell Desensitizer GelEJK · Traditional 11/22/2019SE
K190930SmarTemp X1EBG · Traditional 09/05/2019SE
K182296HyperFil-LVEBF · Traditional 12/14/2018SE
K172176Parkell Universal AdhesiveKLE · Traditional 11/21/2017SE
K151518Brush&Bond PlusKLE · Traditional 09/18/2015SE
K142848Eazy PrimerKLE · Traditional 02/24/2015SE
K132115Absolute Dentin 2EBF · Traditional 06/25/2014SE
K113839Retract Gingival Retraction/Hemostatic PasteMVL · Traditional 04/12/2012SE

Questions and answers

When was Safe-T-Pins Retentive Pin System cleared by the FDA?

Safe-T-Pins Retentive Pin System (K760723) received a 510(k) decision of Substantially Equivalent on October 21, 1976, 24 days after the submission was received.

What is the product code of K760723?

The FDA product code is EBL – Pin, Retentive And Splinting, And Accessory Instruments, a Class I (low risk) device regulated under 21 CFR 872.3740.