| Primary Device ID | 07630031722676 |
| NIH Device Record Key | a0d1a5a1-23fd-4b1d-b6b5-daf988f024f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STRAUMANN ORTHOSYSTEM |
| Version Model Number | Palatal-System |
| Catalog Number | 048.075 |
| 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 | false |
| 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(800)448-8168 |
| info.usa@straumann.com |
| Length | 3.5 Millimeter |
| Length | 3.5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031722676 [Primary] |
| OAT | Implant, endosseous, orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630031722676]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-04 |
| Device Publish Date | 2015-09-24 |
| 07630031722713 | Healing cap, palatal implant, D 4.8mm, H 3.5mm, PEEK |
| 07630031722706 | Cap with transpalatal arch, palatal implant, D 4.8mm, H 5.5mm, stainless steel |
| 07630031722690 | Cap with transpalatal arch, palatal implant, D 4.8mm, H 3.5mm, stainless steel |
| 07630031722683 | Cap, palatal implant, D 4.8mm, H 5.5mm, stainless steel |
| 07630031722676 | Cap, palatal implant, D 4.8mm, H 3.5mm, stainless steel |
| 07630031718174 | Palatal Implant D 4.8 mm SLA 4.2 mm, Ti |
| 07630031718167 | Palatal Implant D 4.1 mm SLA 4.2 mm, Ti |