ITI Dental Implant System 043.722S
GUDID 07630031701046
Tapered Effect Implant, D 3.3mm, RN, SLA 10mm, Ti
Institut Straumann AG
Screw endosteal dental implant, two-piece| Primary Device ID | 07630031701046 |
| NIH Device Record Key | a0cbd5ea-d373-4df0-b169-51557505b19c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ITI Dental Implant System |
| Version Model Number | 1 |
| Catalog Number | 043.722S |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com |
Device Dimensions
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 10 Millimeter |
| Outer Diameter | 3.3 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 |
| 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 | 07630031701046 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012757
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [ITI Dental Implant System]
| 07630031726629 | SCS Occlusal screw for guiding sleeve and post for temp. restorations, L 7.6 mm, TAN |
| 07630031726612 | NN Occlusal screw, L 5mm, D 1.8mm, TAN |
| 07630031719881 | Tapered Effect Implant, D 4.8mm WN, SLA® 14mm, Ti, Loxim™ |
| 07630031719874 | Tapered Effect Implant, D 4.8mm WN, SLA® 12mm, Ti, Loxim™ |
| 07630031719867 | Tapered Effect Implant, D 4.8mm WN, SLA® 10mm, Ti, Loxim™ |
| 07630031719812 | Standard Implant, D 4.8mm WN, SLA® 12mm, Ti, Loxim™ |
| 07630031719805 | Standard Implant, D 4.8mm WN, SLA® 10mm, Ti, Loxim™ |
| 07630031719799 | Standard Implant, D 4.8mm WN, SLA® 8mm, Ti, Loxim™ |
| 07630031719720 | Standard Implant, D 4.8mm RN, SLA® 14mm, Ti, Loxim™ |
| 07630031719713 | Standard Implant, D 4.8mm RN, SLA® 12mm, Ti, Loxim™ |
| 07630031719706 | Standard Implant, D 4.8mm RN, SLA® 10mm, Ti, Loxim™ |
| 07630031719690 | Standard Implant, D 4.8mm RN, SLA® 8mm, Ti, Loxim™ |
| 07630031719676 | Tapered Effect Implant, D 4.1mm RN, SLA® 14mm, Ti, Loxim™ |
| 07630031719669 | Tapered Effect Implant, D 4.1mm RN, SLA® 12mm, Ti, Loxim™ |
| 07630031719652 | Tapered Effect Implant, D 4.1mm RN, SLA® 10mm, Ti, Loxim™ |
| 07630031719645 | Tapered Effect Implant, D 4.1mm RN, SLA® 8mm, Ti, Loxim™ |
| 07630031719584 | Standard Implant, D 4.1mm RN, SLA® 16mm, Ti, Loxim™ |
| 07630031719577 | Standard Implant, D 4.1mm RN, SLA® 14mm, Ti, Loxim™ |
| 07630031719560 | Standard Implant, D 4.1mm RN, SLA® 12mm, Ti, Loxim™ |
| 07630031719553 | Standard Implant, D 4.1mm RN, SLA® 10mm, Ti, Loxim™ |
| 07630031719546 | Standard Implant, D 4.1mm RN, SLA® 8mm, Ti, Loxim™ |
| 07630031719522 | Tapered Effect Implant, D 3.3mm RN, SLA® 14mm, Ti, Loxim™ |
| 07630031719515 | Tapered Effect Implant, D 3.3mm RN, SLA® 12mm, Ti, Loxim™ |
| 07630031719508 | Tapered Effect Implant, D 3.3mm RN, SLA® 10mm, Ti, Loxim™ |
| 07630031719492 | Tapered Effect Implant, D 3.3mm RN, SLA® 8mm, Ti, Loxim™ |
| 07630031719447 | Standard Implant, D 3.3mm RN, SLA® 16mm, Ti, Loxim™ |
| 07630031719430 | Standard Implant, D 3.3mm RN, SLA® 14mm, Ti, Loxim™ |
| 07630031719423 | Standard Implant, D 3.3mm RN, SLA® 12mm, Ti, Loxim™ |
| 07630031719416 | Standard Implant, D 3.3mm RN, SLA® 10mm, Ti, Loxim™ |
| 07630031719409 | Standard Implant, D 3.3mm RN, SLA® 8mm, Ti, Loxim™ |
| 07630031719317 | Tapered Effect Implant, D 4.8mm, WN, SLA 14mm, Ti |
| 07630031719300 | Tapered Effect Implant, D 4.8mm, WN, SLA 12mm, Ti |
| 07630031719294 | Tapered Effect Implant, D 4.8mm, WN, SLA 10mm, Ti |
| 07630031719164 | Standard Implant, D 4.8mm, WN, SLA 12mm, Ti |
| 07630031719157 | Standard Implant, D 4.8mm, WN, SLA 10mm, Ti |
| 07630031719140 | Standard Implant, D 4.8mm, WN, SLA 8mm, Ti |
| 07630031718860 | Standard Implant, D 4.8mm, RN, SLA 14mm, Ti |
| 07630031718853 | Standard Implant, D 4.8mm, RN, SLA 12mm, Ti |
| 07630031718846 | Standard Implant, D 4.8mm, RN, SLA 10mm, Ti |
| 07630031718839 | Standard Implant, D 4.8mm, RN, SLA 8mm, Ti |
| 07630031718624 | Standard Implant, D 3.3mm, RN, SLA 16mm, Ti |
| 07630031718617 | Standard Implant, D 3.3mm, RN, SLA 14mm, Ti |
| 07630031718600 | Standard Implant, D 3.3mm, RN, SLA 12mm, Ti |
| 07630031718594 | Standard Implant, D 3.3mm, RN, SLA 10mm, Ti |
| 07630031718587 | Standard Implant, D 3.3mm, RN, SLA 8mm, Ti |
| 07630031718365 | Standard Implant, D 4.1mm, RN, SLA 16mm, Ti |
| 07630031718358 | Standard Implant, D 4.1mm, RN, SLA 14mm, Ti |
| 07630031718341 | Standard Implant; D 4.1mm, RN, SLA 12mm, Ti |
| 07630031718334 | Standard Implant, D 4.1mm, RN, SLA 10mm, Ti |
| 07630031718327 | Standard Implant, D 4.1mm, RN, SLA 8mm, Ti |
Trademark Results [ITI Dental Implant System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ITI DENTAL IMPLANT SYSTEM 75614838 2454453 Dead/Cancelled |
Institut Straumann AG 1999-01-04 |
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