510(k) K072273
K072273 is an FDA 510(k) premarket notification submitted by Takara Belmont USA, Inc. for the device "BELMONT QUOLIS 5000 SERIES DENTAL UNIT". The FDA issued a decision of Substantially Equivalent on December 20, 2007. The device falls under product code NRD (Unit, Operative Dental, Accessories), a Class I device regulated under 21 CFR 872.6640. Takara Belmont USA, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2007
- Date Received
- August 15, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental, Accessories
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.