510(k) K100182
K100182 is an FDA 510(k) premarket notification submitted by Salvin Dental Specialties, Inc. for the device "SALVIN DENTAL SPECIALTIES FIXATION SCREW". The FDA issued a decision of Substantially Equivalent on May 10, 2010. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Salvin Dental Specialties, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2010
- Date Received
- January 21, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type