Pin, Retentive And Splinting, And Accessory Instruments

FDA product code EBL · Class I (low risk) · 21 CFR 872.3740 · Dental

11510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

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
K760723Safe-T-Pins Retentive Pin SystemEBL · Traditional Parkell, Inc.10/21/1976SE

Recalls

RecallProductFirmInitiated
Z-1494-2021 Class IIDental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the…The incorrect dental pins were packaged and subsequently distributed. Coltene Whaledent Inc03/18/2021Open, Classified