The following data is part of a premarket notification filed by Dentium Co., Ltd with the FDA for Burn-out Cylinder And Angled Screw Abutments.
| Device ID | K160483 |
| 510k Number | K160483 |
| Device Name: | Burn-out Cylinder And Angled Screw Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentium Co., Ltd 150, Eondong-ro, Giheung-gu Yongin-si, KP 443-270 |
| Contact | Sangpil Yoon |
| Correspondent | Younjung Yuk Dentium USA 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 | 2016-02-22 |
| Decision Date | 2016-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809460306217 | K160483 | 000 |
| 08809460306019 | K160483 | 000 |
| 08809460304510 | K160483 | 000 |
| 08809460304503 | K160483 | 000 |
| 08809460304497 | K160483 | 000 |
| 08809460304480 | K160483 | 000 |
| 08809460304473 | K160483 | 000 |
| 08809460304466 | K160483 | 000 |
| 08809460304459 | K160483 | 000 |
| 08809460304442 | K160483 | 000 |
| 08809460300499 | K160483 | 000 |
| 08809460300482 | K160483 | 000 |
| 08809460300475 | K160483 | 000 |
| 08809460300468 | K160483 | 000 |
| 08809460300451 | K160483 | 000 |
| 08809460300444 | K160483 | 000 |
| 08809460300437 | K160483 | 000 |
| 08809460306026 | K160483 | 000 |
| 08809460306033 | K160483 | 000 |
| 08809460306200 | K160483 | 000 |
| 08809460306194 | K160483 | 000 |
| 08809460306187 | K160483 | 000 |
| 08809460306170 | K160483 | 000 |
| 08809460306163 | K160483 | 000 |
| 08809460306156 | K160483 | 000 |
| 08809460306149 | K160483 | 000 |
| 08809460306132 | K160483 | 000 |
| 08809460306125 | K160483 | 000 |
| 08809460306118 | K160483 | 000 |
| 08809460306101 | K160483 | 000 |
| 08809460306095 | K160483 | 000 |
| 08809460306088 | K160483 | 000 |
| 08809460306071 | K160483 | 000 |
| 08809460306064 | K160483 | 000 |
| 08809460306040 | K160483 | 000 |
| 08809460300420 | K160483 | 000 |