510(k) K022264
K022264 is an FDA 510(k) premarket notification submitted by Svenska Dental Instruments AB for the device "CLEAN 'N' OIL". The FDA issued a decision of Substantially Equivalent on October 2, 2002. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Svenska Dental Instruments AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2002
- Date Received
- July 12, 2002
- Clearance Type
- Traditional
- 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