510(k) K100854
K100854 is an FDA 510(k) premarket notification submitted by Premium Plus International Limited for the device "PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399". The FDA issued a decision of Substantially Equivalent on December 9, 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. Premium Plus International Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2010
- Date Received
- March 26, 2010
- 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