510(k) K984556
K984556 is an FDA 510(k) premarket notification submitted by Scholly Fiberoptic GmbH for the device "SCICAN CLASSIC". The FDA issued a decision of Substantially Equivalent on Feb 9, 1999. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Scholly Fiberoptic GmbH has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 1999
- Date Received
- Dec 23, 1998
- 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
- 510(k)