510(k) K050571
K050571 is an FDA 510(k) premarket notification submitted by Eurodent S.P.A. for the device "ABSOLUTE AMERICA". The FDA issued a decision of Substantially Equivalent on November 2, 2005. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Eurodent S.P.A. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2005
- Date Received
- March 4, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type