| Primary Device ID | 07630031740540 |
| NIH Device Record Key | fc7c138c-cf2b-4776-97a2-16a3c3f34a68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann SGL70M |
| Version Model Number | Straumann SGL70M(2.0m) |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031740540 [Primary] |
| EBW | Controller, foot, handpiece and cord |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-29 |
| Device Publish Date | 2018-09-26 |
| 07630031742278 - Straumann TLX Implant System | 2025-06-18 TLX SP Implant, Ø 4.0mm NT, SLA® 8mm, Roxolid® |
| 07630031742285 - Straumann TLX Implant System | 2025-06-18 TLX SP Implant, Ø 4.0mm NT, SLA® 10mm, Roxolid® |
| 07630031703064 - Base metal alloy | 2025-06-16 ticon Titanium primary crown |
| 07630031742261 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 6mm, Roxolid® |
| 07630031742292 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 12mm, Roxolid® |
| 07630031742308 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 14mm, Roxolid® |
| 07630031742315 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 16mm, Roxolid® |
| 07630031742322 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid® |