Elgiloy

FDA 510(k) K883074 · Dale T. Dupuis

Substantially Equivalent

510(k) numberK883074

Submission

Device name
Elgiloy
Applicant
Dale T. Dupuis
Opelousas, LA, US
Received
July 14, 1988
Decision date
August 9, 1988
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
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

More from Parkell, Inc.

510(k)DeviceDecision
K883388Dentrek Bridge BarsEHO · Traditional 10/06/1988SE
K882400Amorphus Silk by DentraxEBF · Traditional 07/15/1988SE

Questions and answers

When was Elgiloy cleared by the FDA?

Elgiloy (K883074) received a 510(k) decision of Substantially Equivalent on August 9, 1988, 26 days after the submission was received.

What is the product code of K883074?

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.