510(k) K061897
K061897 is an FDA 510(k) premarket notification submitted by Orthosource, Inc. for the device "EXCEL CONTRA ANGLE HANDPIECE". The FDA issued a decision of Substantially Equivalent on February 14, 2007. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Orthosource, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2007
- Date Received
- July 3, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type