Dentrek Bridge Bars

FDA 510(k) K883388 · Dale T. Dupuis

Substantially Equivalent

510(k) numberK883388

Submission

Device name
Dentrek Bridge Bars
Applicant
Dale T. Dupuis
Opelousas, LA, US
Received
August 10, 1988
Decision date
October 6, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EHO – Bar, Preformed
Device class
Class I (low risk)
Regulation
21 CFR 872.3165
Specialty
Dental

Other 510(k)s with product code EHO

510(k)DeviceApplicantDecision
K934468Slip-On Fixation Splint (SFS)EHO · Traditional Gatewood Splints08/05/1994SE
K88113370-X/RVG (Radiovisiography)EHO · Traditional Trophy Radiologie07/20/1989SE

More from Trophy Radiologie

510(k)DeviceDecision
K883074ElgiloyEBL · Traditional 08/09/1988SE
K882400Amorphus Silk by DentraxEBF · Traditional 07/15/1988SE

Questions and answers

When was Dentrek Bridge Bars cleared by the FDA?

Dentrek Bridge Bars (K883388) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 57 days after the submission was received.

What is the product code of K883388?

The FDA product code is EHO – Bar, Preformed, a Class I (low risk) device regulated under 21 CFR 872.3165.