| Primary Device ID | 07630031755438 | 
| NIH Device Record Key | 8ca5928c-6185-4b78-8c42-a8ff903f86cd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | 
| Version Model Number | SLA Roxolid BL | 
| Catalog Number | 061.9516 | 
| Company DUNS | 483599259 | 
| Company Name | Institut Straumann AG | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Conditional | 
| 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 | 
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 | 
| info.usa@straumann.com | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Outer Diameter | 6.5 Millimeter | 
| Length | 16 Millimeter | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07630031755438 [Primary] | 
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-03-09 | 
| Device Publish Date | 2022-03-01 | 
| 07630031755438 | BLX Implant, Ø 6.5mm WB, SLA® 16mm, Roxolid® | 
| 07630031755421 | BLX Implant, Ø 6.5mm WB, SLA® 14mm, Roxolid® | 
| 07630031755414 | BLX Implant, Ø 6.5mm WB, SLActive® 16mm, Roxolid® | 
| 07630031755407 | BLX Implant, Ø 6.5mm WB, SLActive® 14mm, Roxolid® | 
| 07630031755391 | BLX Implant, Ø 5.5mm WB, SLA® 16mm, Roxolid® | 
| 07630031755384 | BLX Implant, Ø 5.5mm WB, SLA® 14mm, Roxolid® | 
| 07630031755377 | BLX Implant, Ø 5.5mm WB, SLActive® 16mm, Roxolid® | 
| 07630031755360 | BLX Implant, Ø 5.5mm WB, SLActive® 14mm, Roxolid® | 
| 07630031743848 | BLX Implant, Ø 5.0mm WB, SLA® 18mm, Roxolid® |