The following data is part of a premarket notification filed by Teledyne Densco with the FDA for Dental Rotary Carbide Burs 76ejl.
Device ID | K780641 |
510k Number | K780641 |
Device Name: | DENTAL ROTARY CARBIDE BURS 76EJL |
Classification | Bur, Dental |
Applicant | TELEDYNE DENSCO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-17 |
Decision Date | 1978-04-21 |