The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Simply Iconic Implants.
| Device ID | K201553 |
| 510k Number | K201553 |
| Device Name: | Simply Iconic Implants |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2021-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307125976 | K201553 | 000 |
| 10841307125112 | K201553 | 000 |
| 10841307125105 | K201553 | 000 |
| 10841307125099 | K201553 | 000 |
| 10841307125082 | K201553 | 000 |
| 10841307125075 | K201553 | 000 |
| 10841307125068 | K201553 | 000 |
| 10841307125051 | K201553 | 000 |
| 10841307125044 | K201553 | 000 |
| 10841307125037 | K201553 | 000 |
| 10841307125020 | K201553 | 000 |
| 10841307125013 | K201553 | 000 |
| 10841307125006 | K201553 | 000 |
| 10841307124993 | K201553 | 000 |
| 10841307124986 | K201553 | 000 |
| 10841307124979 | K201553 | 000 |
| 10841307124962 | K201553 | 000 |
| 10841307124955 | K201553 | 000 |
| 10841307125129 | K201553 | 000 |
| 10841307125136 | K201553 | 000 |
| 10841307125143 | K201553 | 000 |
| 10841307125969 | K201553 | 000 |
| 10841307125952 | K201553 | 000 |
| 10841307125297 | K201553 | 000 |
| 10841307125280 | K201553 | 000 |
| 10841307125273 | K201553 | 000 |
| 10841307125266 | K201553 | 000 |
| 10841307125259 | K201553 | 000 |
| 10841307125242 | K201553 | 000 |
| 10841307125235 | K201553 | 000 |
| 10841307125228 | K201553 | 000 |
| 10841307125211 | K201553 | 000 |
| 10841307125204 | K201553 | 000 |
| 10841307125198 | K201553 | 000 |
| 10841307125181 | K201553 | 000 |
| 10841307125174 | K201553 | 000 |
| 10841307125167 | K201553 | 000 |
| 10841307125150 | K201553 | 000 |
| 10841307124948 | K201553 | 000 |