SIMPLY ICONIC™ Implant 675713RP
GUDID 10841307125976
5.7mmD x 13mmL, 3.4mmD Platform
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant system| Primary Device ID | 10841307125976 |
| NIH Device Record Key | eceebcf6-d78b-40f4-9509-9d20a7b051d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLY ICONIC™ Implant |
| Version Model Number | 675713RP |
| Catalog Number | 675713RP |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307125976 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201553
FDA Product Code
| DZE | Implant, Endosseous, Root-Form |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
On-Brand Devices [SIMPLY ICONIC™ Implant]
| 10841307125976 | 5.7mmD x 13mmL, 3.4mmD Platform |
| 10841307125969 | 4.7mmD x 16mmL, 3.4mmD Platform |
| 10841307125952 | 4.7mmD x 16mmL, 3.0mmD Platform |
| 10841307125297 | 5.7mmD x 11.5mmL, 3.4mmD Platform |
| 10841307125280 | 5.7mmD x 10mmL, 3.4mmD Platform |
| 10841307125273 | 5.7mmD x 8mmL, 3.4mmD Platform |
| 10841307125266 | 5.7mmD x 6mmL, 3.4mmD Platform |
| 10841307125259 | 5.2mmD x 13mmL, 3.4mmD Platform |
| 10841307125242 | 5.2mmD x 11.5mmL, 3.4mmD Platform |
| 10841307125235 | 5.2mmD x 10mmL, 3.4mmD Platform |
| 10841307125228 | 5.2mmD x 8mmL, 3.4mmD Platform |
| 10841307125211 | 5.2mmD x 6mmL, 3.4mmD Platform |
| 10841307125204 | 4.7mmD x 13mmL, 3.4mmD Platform |
| 10841307125198 | 4.7mmD x 11.5mmL, 3.4mmD Platform |
| 10841307125181 | 4.7mmD x 10mmL, 3.4mmD Platform |
| 10841307125174 | 4.7mmD x 8mmL, 3.4mmD Platform |
| 10841307125167 | 4.7mmD x 6mmL, 3.4mmD Platform |
| 10841307125150 | 4.7mmD x 13mmL, 3.0mmD Platform |
| 10841307125143 | 4.7mmD x 11.5mmL, 3.0mmD Platform |
| 10841307125136 | 4.7mmD x 10mmL, 3.0mmD Platform |
| 10841307125129 | 4.7mmD x 8mmL, 3.0mmD Platform |
| 10841307125112 | 4.7mmD x 6mmL, 3.0mmD Platform |
| 10841307125105 | 4.2mmD x 16mmL, 3.0mmD Platform |
| 10841307125099 | 4.2mmD x 13mmL, 3.0mmD Platform |
| 10841307125082 | 4.2mmD x 11.5mmL, 3.0mmD Platform |
| 10841307125075 | 4.2mmD x 10mmL, 3.0mmD Platform |
| 10841307125068 | 4.2mmD x 8mmL, 3.0mmD Platform |
| 10841307125051 | 4.2mmD x 6mmL, 3.0mmD Platform |
| 10841307125044 | 3.7mmD x 16mmL, 3.0mmD Platform |
| 10841307125037 | 3.7mmD x 13mmL, 3.0mmD Platform |
| 10841307125020 | 3.7mmD x 11.5mmL, 3.0mmD Platform |
| 10841307125013 | 3.7mmD x 10mmL, 3.0mmD Platform |
| 10841307125006 | 3.7mmD x 8mmL, 3.0mmD Platform |
| 10841307124993 | 3.7mmD x 6mmL, 3.0mmD Platform |
| 10841307124986 | 3.2mmD x 16mmL, 3.0mmD Platform |
| 10841307124979 | 3.2mmD x 13mmL, 3.0mmD Platform |
| 10841307124962 | 3.2mmD x 11.5mmL, 3.0mmD Platform |
| 10841307124955 | 3.2mmD x 10mmL, 3.0mmD Platform |
| 10841307124948 | 3.2mmD x 8mmL, 3.0mmD Platform |
Trademark Results [SIMPLY ICONIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLY ICONIC 97570297 not registered Live/Pending |
Implant Direct Sybron International LLC 2022-08-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.