The following data is part of a premarket notification filed by Dentium Co. Ltd. with the FDA for Dentium Implantium And Superline Abutments.
| Device ID | K141457 |
| 510k Number | K141457 |
| Device Name: | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DENTIUM CO. LTD. 6761 KATELLA AVE. Cypress, CA 90630 |
| Contact | Sheryl Higgins |
| Correspondent | Sheryl Higgins DENTIUM CO. LTD. 6761 KATELLA AVE. Cypress, CA 90630 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809460301335 | K141457 | 000 |
| 08809460301328 | K141457 | 000 |
| 08809460301311 | K141457 | 000 |
| 08809460301304 | K141457 | 000 |
| 08809460301274 | K141457 | 000 |
| 08809460301267 | K141457 | 000 |
| 08809460301250 | K141457 | 000 |
| 08809460301243 | K141457 | 000 |
| 08809460300413 | K141457 | 000 |