510(k) K955573
K955573 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "OPTIBLAST INTRAORAL SANDBLASTER". The FDA issued a decision of Substantially Equivalent on May 3, 1996. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Buffalo Dental Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1996
- Date Received
- December 7, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airbrush
- Device Class
- Class II
- Regulation Number
- 872.6080
- Review Panel
- DE
- Submission Type