| Primary Device ID | 04260468254858 |
| NIH Device Record Key | 723c401f-92f8-4684-8629-e6c330c28272 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SDS Insertion tool remover |
| Version Model Number | SDS_ITR |
| Company DUNS | 487103033 |
| Company Name | SDS Swiss Dental Solutions AG |
| 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 | true |
| 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 | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com | |
| Phone | (774) 634-6225 |
| info.us@swissdentalsolutions.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260468254858 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
[04260468254858]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-11-28 |
| 04260468254858 - SDS Insertion tool remover | 2025-12-08 |
| 04260468254858 - SDS Insertion tool remover | 2025-12-08 |
| 04260468254483 - BISS | 2021-05-03 BISS osteo tray |
| 04260468254506 - BISS | 2021-05-03 BISS osteotome 3.8 |
| 04260468254513 - BISS | 2021-05-03 BISS osteotome 4.6 |
| 04260468254520 - BISS | 2021-05-03 BISS osteotome 5.4 |
| 04260468254537 - BISS | 2021-05-03 BISS hammer |
| 04260468252007 - SDS1.2/ SDS2.2 | 2020-08-14 Round bur |
| 04260468252014 - SDS1.2/ SDS2.2 | 2020-08-14 Pilot drill |