The following data is part of a premarket notification filed by Osteoready Llc with the FDA for Osteoready Zircoseal Abutments.
| Device ID | K151169 |
| 510k Number | K151169 |
| Device Name: | OsteoReady ZircoSeal Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | OsteoReady LLC 106 Lenora Street Seattle, WA 98121 |
| Contact | Michael D Silverman |
| Correspondent | Daniela Levy Sterling Medical Registration 22817 Ventura Blvd Woodland Hills, CA 91364 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-10-08 |
| Summary: | summary |