Tin Coated Dental Burs

FDA 510(k) K911208 · Surgical Precision Instruments, Corp.

Substantially Equivalent

510(k) numberK911208

Submission

Device name
Tin Coated Dental Burs
Applicant
Surgical Precision Instruments, Corp.
Barrington, NH, US
Received
March 19, 1991
Decision date
September 16, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJL – Bur, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.3240
Specialty
Dental

Other 510(k)s with product code EJL

510(k)DeviceApplicantDecision
K080687SmartbursEJL · Traditional S.S. White Burs, Inc.06/20/2008SE
K071352CeradrillEJL · Traditional Gebr. Brasseler GmbH & Co. KG06/29/2007SE
K061383Bti Sterile Dental Drills Kit, Bti Abutments and CapsEJL · Traditional B.T.I. Biotechnology Institute, Sl.08/03/2006SE
K943273Tri Hawk Bur, FG BurEJL · Traditional Tri Hawk Corp.08/01/1994SE
K926205MonosterylEJL · Traditional Utensili Super Abrasivi02/10/1994SE
K923883Dental or Surgical BurEJL · Traditional Stratum Dental Technologies, Inc.07/27/1993SE
K921406Silicont Bur BlockEJL · Traditional Innovators, Inc.04/28/1992SE
K920243Smart Burs Total CarbidesEJL · Traditional Vermont Diamond Instruments03/25/1992SE
K910794Small Instrument Sterilization/Bur BoxEJL · Traditional Brevet, Inc.05/23/1991SE
K882183Dental BursEJL · Traditional Tri-Stage, Inc.06/21/1988SE

Questions and answers

When was Tin Coated Dental Burs cleared by the FDA?

Tin Coated Dental Burs (K911208) received a 510(k) decision of Substantially Equivalent on September 16, 1991, 181 days after the submission was received.

What is the product code of K911208?

The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.