The following data is part of a premarket notification filed by Stratum Dental Technologies, Inc. with the FDA for Dental Or Surgical Bur.
Device ID | K923883 |
510k Number | K923883 |
Device Name: | DENTAL OR SURGICAL BUR |
Classification | Bur, Dental |
Applicant | STRATUM DENTAL TECHNOLOGIES, INC. 1000 WEST BONANZA RD. Las Vegas, NV 89106 |
Contact | K. L Hall |
Correspondent | K. L Hall STRATUM DENTAL TECHNOLOGIES, INC. 1000 WEST BONANZA RD. Las Vegas, NV 89106 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-04 |
Decision Date | 1993-07-27 |