510(k) K885133
K885133 is an FDA 510(k) premarket notification submitted by Asahi Optical Co. C/O Rosati Associates, P.C. for the device "APACERAM ARTIFICIAL DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Asahi Optical Co. C/O Rosati Associates, P.C. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1989
- Date Received
- December 12, 1988
- 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