The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing Llc with the FDA for Interactive Smartbase Abutments.
| Device ID | K181359 |
| 510k Number | K181359 |
| Device Name: | InterActive SMARTBase Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Contact | Reina Choi |
| Correspondent | Reina Choi Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-22 |
| Decision Date | 2018-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307123231 | K181359 | 000 |
| 10841307129141 | K181359 | 000 |
| 10841307129134 | K181359 | 000 |
| 10841307129127 | K181359 | 000 |
| 10841307129110 | K181359 | 000 |
| 10841307129103 | K181359 | 000 |
| 10841307129097 | K181359 | 000 |
| 10841307129080 | K181359 | 000 |
| 10841307129073 | K181359 | 000 |
| 10841307129158 | K181359 | 000 |
| 10841307123149 | K181359 | 000 |
| 10841307123224 | K181359 | 000 |
| 10841307123217 | K181359 | 000 |
| 10841307123200 | K181359 | 000 |
| 10841307123194 | K181359 | 000 |
| 10841307123187 | K181359 | 000 |
| 10841307123170 | K181359 | 000 |
| 10841307123163 | K181359 | 000 |
| 10841307123156 | K181359 | 000 |
| 10841307129066 | K181359 | 000 |