| Primary Device ID | 07392532181276 | 
| NIH Device Record Key | 9b34886b-3479-45f0-9a56-9c01dcccd986 | 
| Commercial Distribution Discontinuation | 2020-01-01 | 
| Commercial Distribution Status | Not in Commercial Distribution | 
| Brand Name | SIMPLANT® | 
| Version Model Number | Version 2 | 
| Catalog Number | 54500395IV | 
| 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 | false | 
| Lot Batch | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)531-3481 | 
| implants-na-cs@dentsplysirona.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07392532181276 [Primary] | 
| LLZ | System, image processing, radiological | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2020-03-05 | 
| Device Publish Date | 2016-09-30 | 
| 07392532181276 | SIMPLANT Viewer | 
| 07392532181252 | SIMPLANT Editor | 
| 07392532178030 | SIMPLANT Pro | 
| 07392532177286 | Immediate Smile Complete | 
| 07392532177279 | Immediate Smile bridge | 
| 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 |