Root Canal Post

FDA 510(k) K924376 · The Thera Group

Substantially Equivalent

510(k) numberK924376

Submission

Device name
Root Canal Post
Applicant
The Thera Group
Westford, MA, US
Received
August 28, 1992
Decision date
November 22, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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

Questions and answers

When was Root Canal Post cleared by the FDA?

Root Canal Post (K924376) received a 510(k) decision of Substantially Equivalent on November 22, 1993, 451 days after the submission was received.

What is the product code of K924376?

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.