| Primary Device ID | 07630031724830 | 
| NIH Device Record Key | 85414c0e-8ddf-4733-bb8b-33b99d0fecfb | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Straumann Extraoral Implant System | 
| Version Model Number | EO | 
| Catalog Number | 048.526 | 
| Company DUNS | 483599259 | 
| Company Name | Institut Straumann AG | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | |
| 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 | |
| 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 | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Length | 3.5 Millimeter | 
| Angle | 15 degree | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07630031724830 [Primary] | 
| KCZ | PROSTHESIS, BREAST, EXTERNAL, USED WITH ADHESIVE | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
[07630031724830]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-12-12 | 
| Device Publish Date | 2022-12-02 | 
| 07630031722409 | EO Healing cap, D 3.5mm, L 3.8mm, Ti | 
| 07630031724878 | EO Paralleling guide, Ø 3.5mm, L 15.0mm, stainless steel | 
| 07630031724830 | EO conical abutment 15° short, Neck lenght 5.5 mm, Titanium | 
| 07630031724823 | EO conical abutment 15° short, Neck lenght 3.5 mm, Titanium | 
| 07630031723703 | EO Gold cap 15°, Ø 4.8mm, L 5.5mm, ceramicon | 
| 07630031721433 | EO implant iserting device, Length 10.0 mm, Stainless steel, PEEK | 
| 07630031720016 | EO Stop drill for implant 042.362S Ø 2.8mm, L 24mm, stainless steel | 
| 07630031720009 | EO Stop drill for implant 042.360S Ø 2.8mm, L 22.5mm, stainless steel | 
| 07630031719997 | EO Profile drill for implant 042.367S Ø 2.8mm, L 25mm, stainless steel | 
| 07630031719980 | EO Profile drill for implant 042.365S Ø 2.8mm, L 25mm, stainless steel | 
| 07630031718211 | EO implant Ø 3.3 / 5.5 mm, Insertion depth 4.0 mm, Titanium | 
| 07630031718204 | EO implant Ø 3.3 / 5.5 mm, Insertion depth 2.5 mm, Titanium | 
| 07630031718198 | EO implant Ø 3.3 / 3.5 mm, Insertion depth 5.0 mm, Titanium | 
| 07630031718181 | EO implant Ø 3.3 / 3.5 mm, Insertion depth 3.5 mm, Titanium |