510(k) K100192
K100192 is an FDA 510(k) premarket notification submitted by Saeshin Precision Co., Ltd. for the device "STRONG DENTAL HANDPIECES". The FDA issued a decision of Substantially Equivalent on February 4, 2010. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Saeshin Precision Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2010
- Date Received
- January 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type