The following data is part of a premarket notification filed by Juell Dental with the FDA for Osi O-ball Abutment Head Implants.
| Device ID | K110548 |
| 510k Number | K110548 |
| Device Name: | OSI O-BALL ABUTMENT HEAD IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JUELL DENTAL 2401 N COMMERCE Ardmore, OK 73401 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell JUELL DENTAL 2401 N COMMERCE Ardmore, OK 73401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-25 |
| Decision Date | 2011-07-29 |
| Summary: | summary |