510(k) K854643
K854643 is an FDA 510(k) premarket notification submitted by Alpine Dental Equipment Co. for the device "SOLAR". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Alpine Dental Equipment Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1986
- Date Received
- November 19, 1985
- Clearance Type
- Traditional
- 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