Straumann® BLC and TLC Implants 035.5318S
GUDID 07630031764997
TLC S Implant, Ø 3.75mm RT, SLActive® 18mm, Roxolid®
Institut Straumann AG
Screw endosteal dental implant, two-piece| Primary Device ID | 07630031764997 |
| NIH Device Record Key | 84af0459-e1e6-4791-9ba7-6ef94aa40ef9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann® BLC and TLC Implants |
| Version Model Number | SLActive Roxolid TL |
| Catalog Number | 035.5318S |
| 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
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.75 Millimeter |
| Length | 18 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 | 07630031764997 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230108
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 | 2023-11-13 |
| Device Publish Date | 2023-11-04 |
On-Brand Devices [Straumann® BLC and TLC Implants]
| 07630031766816 | TLC SP Implant, Ø 4.5mm WT, SLActive® 18mm, Roxolid® |
| 07630031766809 | TLC SP Implant, Ø 4.5mm WT, SLActive® 16mm, Roxolid® |
| 07630031766793 | TLC SP Implant, Ø 4.5mm WT, SLActive® 14mm, Roxolid® |
| 07630031766786 | TLC SP Implant, Ø 4.5mm WT, SLActive® 12mm, Roxolid® |
| 07630031766779 | TLC SP Implant, Ø 4.5mm WT, SLActive® 10mm, Roxolid® |
| 07630031766762 | TLC SP Implant, Ø 4.5mm WT, SLActive® 8mm, Roxolid® |
| 07630031766755 | TLC SP Implant, Ø 4.5mm WT, SLActive® 6mm, Roxolid® |
| 07630031766748 | TLC SP Implant, Ø 3.3mm RT, SLActive® 18mm, Roxolid® |
| 07630031766731 | TLC SP Implant, Ø 3.3mm RT, SLActive® 16mm, Roxolid® |
| 07630031766724 | TLC SP Implant, Ø 3.3mm RT, SLActive® 14mm, Roxolid® |
| 07630031766717 | TLC SP Implant, Ø 3.3mm RT, SLActive® 12mm, Roxolid® |
| 07630031766700 | TLC SP Implant, Ø 3.3mm RT, SLActive® 10mm, Roxolid® |
| 07630031766694 | TLC SP Implant, Ø 3.3mm RT, SLActive® 8mm, Roxolid® |
| 07630031766670 | TLC SP Implant, Ø 4.5mm WT, SLA® 18mm, Roxolid® |
| 07630031766663 | TLC SP Implant, Ø 4.5mm WT, SLA® 16mm, Roxolid® |
| 07630031766656 | TLC SP Implant, Ø 4.5mm WT, SLA® 14mm, Roxolid® |
| 07630031766649 | TLC SP Implant, Ø 4.5mm WT, SLA® 12mm, Roxolid® |
| 07630031766632 | TLC SP Implant, Ø 4.5mm WT, SLA® 10mm, Roxolid® |
| 07630031766625 | TLC SP Implant, Ø 4.5mm WT, SLA® 8mm, Roxolid® |
| 07630031766618 | TLC SP Implant, Ø 4.5mm WT, SLA® 6mm, Roxolid® |
| 07630031766601 | TLC SP Implant, Ø 3.3mm RT, SLA® 18mm, Roxolid® |
| 07630031766595 | TLC SP Implant, Ø 3.3mm RT, SLA® 16mm, Roxolid® |
| 07630031766588 | TLC SP Implant, Ø 3.3mm RT, SLA® 14mm, Roxolid® |
| 07630031766571 | TLC SP Implant, Ø 3.3mm RT, SLA® 12mm, Roxolid® |
| 07630031766564 | TLC SP Implant, Ø 3.3mm RT, SLA® 10mm, Roxolid® |
| 07630031766557 | TLC SP Implant, Ø 3.3mm RT, SLA® 8mm, Roxolid® |
| 07630031766533 | TLC S Implant, Ø 4.5mm WT, SLActive® 18mm, Roxolid® |
| 07630031766526 | TLC S Implant, Ø 4.5mm WT, SLActive® 16mm, Roxolid® |
| 07630031766519 | TLC S Implant, Ø 4.5mm WT, SLActive® 14mm, Roxolid® |
| 07630031766502 | TLC S Implant, Ø 4.5mm WT, SLActive® 12mm, Roxolid® |
| 07630031766496 | TLC S Implant, Ø 4.5mm WT, SLActive® 10mm, Roxolid® |
| 07630031766489 | TLC S Implant, Ø 4.5mm WT, SLActive® 8mm, Roxolid® |
| 07630031766472 | TLC S Implant, Ø 4.5mm WT, SLActive® 6mm, Roxolid® |
| 07630031766465 | TLC S Implant, Ø 3.3mm RT, SLActive® 18mm, Roxolid® |
| 07630031766458 | TLC S Implant, Ø 3.3mm RT, SLActive® 16mm, Roxolid® |
| 07630031766441 | TLC S Implant, Ø 3.3mm RT, SLActive® 14mm, Roxolid® |
| 07630031766434 | TLC S Implant, Ø 3.3mm RT, SLActive® 12mm, Roxolid® |
| 07630031766427 | TLC S Implant, Ø 3.3mm RT, SLActive® 10mm, Roxolid® |
| 07630031766410 | TLC S Implant, Ø 3.3mm RT, SLActive® 8mm, Roxolid® |
| 07630031766403 | TLC S Implant, Ø 4.5mm WT, SLA® 18mm, Roxolid® |
| 07630031766397 | TLC S Implant, Ø 4.5mm WT, SLA® 16mm, Roxolid® |
| 07630031766380 | TLC S Implant, Ø 4.5mm WT, SLA® 14mm, Roxolid® |
| 07630031766373 | TLC S Implant, Ø 4.5mm WT, SLA® 12mm, Roxolid® |
| 07630031766366 | TLC S Implant, Ø 4.5mm WT, SLA® 10mm, Roxolid® |
| 07630031766359 | TLC S Implant, Ø 4.5mm WT, SLA® 8mm, Roxolid® |
| 07630031766342 | TLC S Implant, Ø 4.5mm WT, SLA® 6mm, Roxolid® |
| 07630031766335 | TLC S Implant, Ø 3.3mm RT, SLA® 18mm, Roxolid® |
| 07630031766328 | TLC S Implant, Ø 3.3mm RT, SLA® 16mm, Roxolid® |
| 07630031766311 | TLC S Implant, Ø 3.3mm RT, SLA® 14mm, Roxolid® |
| 07630031766304 | TLC S Implant, Ø 3.3mm RT, SLA® 12mm, 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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