510(k) K131451
K131451 is an FDA 510(k) premarket notification submitted by Paltop Advanced Dental Solutions, Ltd. for the device "PALTOP DENTAL IMPLANT - STERILE ACCESSORIES". The FDA issued a decision of Substantially Equivalent on August 22, 2013. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Paltop Advanced Dental Solutions, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2013
- Date Received
- May 20, 2013
- Clearance Type
- Special
- 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