510(k) K813227
K813227 is an FDA 510(k) premarket notification submitted by Pacific Implant, Inc. for the device "INTRAOSSEOUS DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Pacific Implant, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1981
- Date Received
- November 10, 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