510(k) K813257
K813257 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "ALVEOGRAF DURAPATITE(18-40 MESH)". The FDA issued a decision of Substantially Equivalent on January 5, 1982. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1982
- Date Received
- November 19, 1981
- Clearance Type
- Traditional
- 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