SIMPLANT®
GUDID 07392532177279
Immediate Smile bridge
Dentsply Implants NV
Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge| Primary Device ID | 07392532177279 |
| NIH Device Record Key | 5b7cc8b8-72b9-4921-b4a4-84e0bc9b655c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLANT® |
| Version Model Number | 54500215 |
| Company DUNS | 764142159 |
| Company Name | Dentsply Implants NV |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Storage in the original packaging, in a dry place, at normal room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07392532177279 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113739
FDA Product Code
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-16 |
On-Brand Devices [SIMPLANT®]
| 07392532181276 | SIMPLANT Viewer |
| 07392532181252 | SIMPLANT Editor |
| 07392532178030 | SIMPLANT Pro |
| 07392532177286 | Immediate Smile Complete |
| 07392532177279 | Immediate Smile bridge |
Trademark Results [SIMPLANT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLANT 79016792 3171725 Live/Registered |
DENTSPLY Implants NV 2004-10-27 |
 SIMPLANT 77848515 3877954 Dead/Cancelled |
WomanCare Global LLC 2009-10-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.