Securipin

FDA 510(k) K844457 · Hughes Int'L, Inc.

Substantially Equivalent

510(k) numberK844457

Submission

Device name
Securipin
Applicant
Hughes Int'L, Inc.
Hunt Valley, MD, US
Received
November 16, 1984
Decision date
December 27, 1984
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
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 Securipin cleared by the FDA?

Securipin (K844457) received a 510(k) decision of Substantially Equivalent on December 27, 1984, 41 days after the submission was received.

What is the product code of K844457?

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.