510(k) K133362
K133362 is an FDA 510(k) premarket notification submitted by Sgs International, Ltd. for the device "SGS DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on Nov 21, 2014. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sgs International, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 21, 2014
- Date Received
- Nov 1, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)