Straumann® BLC and TLC Implants - Line extension 035.7814S
GUDID 07630031766267
TLC SP Implant, Ø 6.5mm WT, SLActive 14mm, Roxolid
Institut Straumann AG
Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece| Primary Device ID | 07630031766267 |
| NIH Device Record Key | dba41fcb-14fa-4ccb-b10e-95da60a4afef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann® BLC and TLC Implants - Line extension |
| Version Model Number | SLActive Roxolid TL |
| Catalog Number | 035.7814S |
| 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 |
Customer Support Contacts
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com |
Device Dimensions
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 6.5 Millimeter |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031766267 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K234049
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-13 |
| Device Publish Date | 2024-05-03 |
On-Brand Devices [Straumann® BLC and TLC Implants - Line extension]
| 07630031766274 | TLC SP Implant, Ø 6.5mm WT, SLActive 16mm, Roxolid |
| 07630031766267 | TLC SP Implant, Ø 6.5mm WT, SLActive 14mm, Roxolid |
| 07630031766250 | TLC SP Implant, Ø 6.5mm WT, SLActive 12mm, Roxolid |
| 07630031766212 | TLC SP Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid |
| 07630031766205 | TLC SP Implant, Ø 5.5mm WT, SLActive 14mm, Roxolid |
| 07630031765789 | TLC S Implant, Ø 6.5mm WT, SLActive 16mm, Roxolid |
| 07630031765772 | TLC S Implant, Ø 6.5mm WT, SLActive 14mm, Roxolid |
| 07630031765765 | TLC S Implant, Ø 6.5mm WT, SLActive 12mm, Roxolid |
| 07630031765758 | TLC S Implant, Ø 6.5mm WT, SLActive 10mm, Roxolid |
| 07630031765741 | TLC S Implant, Ø 6.5mm WT, SLActive 8mm, Roxolid |
| 07630031765727 | TLC S Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid |
| 07630031765710 | TLC S Implant, Ø 5.5mm WT, SLActive 14mm, Roxolid |
| 07630031764713 | BLC Implant, Ø 6.5mm WB, SLActive 16mm, Roxolid |
Trademark Results [Straumann]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRAUMANN 78575002 3360454 Dead/Cancelled |
Straumann Holding AG 2005-02-25 |
 STRAUMANN 78455752 3708723 Live/Registered |
Straumann Holding AG 2004-07-23 |
 STRAUMANN 76533946 3043249 Live/Registered |
Straumann Holding AG 2003-07-31 |
 STRAUMANN 74505688 1998968 Live/Registered |
STRAUMANN HOLDING AG 1994-03-25 |
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