510(k) K031793
K031793 is an FDA 510(k) premarket notification submitted by Dentatus USA , Ltd. for the device "DENTATUS OSCIOMAT". The FDA issued a decision of Substantially Equivalent on November 13, 2003. The device falls under product code DZH (Saw, Bone, Ac-Powered), a Class II device regulated under 21 CFR 872.4120. Dentatus USA , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2003
- Date Received
- June 10, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saw, Bone, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type