The following data is part of a premarket notification filed by Buffalo Dental Mfg. Co., Inc. with the FDA for Optiblast Intraoral Sandblaster.
Device ID | K955573 |
510k Number | K955573 |
Device Name: | OPTIBLAST INTRAORAL SANDBLASTER |
Classification | Airbrush |
Applicant | BUFFALO DENTAL MFG. CO., INC. 99 LAFAYETTE DR. Syosset, NY 11791 |
Contact | Don M Nevin |
Correspondent | Don M Nevin BUFFALO DENTAL MFG. CO., INC. 99 LAFAYETTE DR. Syosset, NY 11791 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-07 |
Decision Date | 1996-05-03 |