Submission Details
| 510(k) Number | K073032 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2007 |
| Decision Date | November 16, 2007 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K073032 is an FDA 510(k) clearance for the PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on November 16, 2007, 21 days after receiving the submission on October 26, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.
| 510(k) Number | K073032 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2007 |
| Decision Date | November 16, 2007 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA — Abutment, Implant, Dental, Endosseous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |