| Primary Device ID | D010606659001 |
| NIH Device Record Key | 38060306-d14c-4080-a9ce-75ea3eeccecd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dentsply Sirona |
| Version Model Number | 60665900 |
| Catalog Number | 60665900 |
| Company DUNS | 315471722 |
| Company Name | Dentsply De Trey GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D010606659001 [Primary] |
| HIBCC | D010K1027640 [Direct Marking] |
| DZN | INSTRUMENTS, DENTAL HAND |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-18 |
| Device Publish Date | 2023-08-10 |
| D01060620110NA1 - AH Plus Endodontic Sealer Tubes | 2025-04-08 AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an |
| D01060620115NA1 - AH Plus Jet Endodontic Sealer Starter Kit | 2025-04-08 AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin |
| D01060620118NA0 - AH Plus Jet Endodontic Sealer Syringe Refill | 2025-04-08 AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin |
| D0106425400 - TPH Spectra ST | 2024-03-06 TPH Spectra ST Effects is a visible light-cured, radiopaque, composite restorative for anterior and posterior restorations and c |
| D0106425410 - TPH Spectra ST | 2024-03-06 TPH Spectra ST and TPH Spectra ST Effects are visible light-cured, radiopaque, composite restorative for anterior and posterior |
| D0106425420 - TPH Spectra ST | 2024-03-06 TPH Spectra ST Effects Compules Tips Intro Kit is a visible light-cured, radiopaque, composite restorative for anterior and post |
| D0106425430 - TPH Spectra ST | 2024-03-06 TPH Spectra ST Effects Compules Tips Refill D1 is a visible light-cured, radiopaque, composite restorative for anterior and post |
| D0106425440 - TPH Spectra ST | 2024-03-06 TPH Spectra ST Effects Compules Tips Refill D3 is a visible light-cured, radiopaque, composite restorative for anterior and post |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DENTSPLY SIRONA 88421196 5919456 Live/Registered |
Dentsply Sirona Inc. 2019-05-08 |
![]() DENTSPLY SIRONA 88421172 5919453 Live/Registered |
Dentsply Sirona Inc. 2019-05-08 |
![]() DENTSPLY SIRONA 88421151 5914522 Live/Registered |
Dentsply Sirona Inc. 2019-05-08 |
![]() DENTSPLY SIRONA 88421133 5914519 Live/Registered |
Dentsply Sirona Inc. 2019-05-08 |