FDA Registration
Active
🇨🇭 Switzerland
NNC Closure Screw, H0 (4-pack)
Reg #: 9613348
·
FEI: 3004975279
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INSTITUT STRAUMANN AG
- Registration Number
- 9613348
- FEI Number
- 3004975279
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PETER MERIAN-WEG 12
- City
- BASEL Basel-Stadt
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K161677
Owner / Operator
- Firm Name
- INSTITUT STRAUMANN AG
- Operator Number
- 9005052
- Address
- PETER MERIAN-WEG 12
- City
- BASEL
- State
- CH-NOTA
- Postal Code
- CH-4002
- Country
- CH
- Correspondent
- Andreas Petermann
US Agent
- Business Name
- Straumann USA, LLC
- Contact Name
- Jennifer M. Jackson
- Address
- 60 Minuteman Road
- City
- Andover
- State
- MA
- ZIP
- 01810
- Country
- US
- [email protected]
- Phone
- 978 7472509
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2016-10-17 |
Proprietary Names
NNC Closure Screw, H0 (4-pack)
RC Closure Screw, H0 (4-pack)
RC Closure Cap for Fixation Cap, Ti
RC Healing Abutment, conical diameter 4.5, H6
NC Fixation Cap, Ti
NC Closure Screw, H0
NC Closure Screw, H0 (4-pack)
NC Closure Screw, H0.5
NNC Closure Screw, H0
RC Healing Abutment, conical diameter 4.5, H2
RC Closure Screw, H0.5
RC Closure Screw, H0.5 (4-pack)
RN Closure Cap, H1.5, Ti (4-pack)
RC Closure Screw, H0
NC Closure Screw, H0.5 (4-pack)
RC Closure & Fixation Cap, diameter 5.5mm, Ti
RC Healing Abutment, conical diameter 6, H2
RC Healing Abutment, conical diameter 4.5, H4
NNC Closure Screw, H0.5 (4-pack)
NC Closure & Fixation Cap, diameter 5.5mm, Ti
NC Closure Cap for Fixation Cap, Ti
RC Fixation Cap, Ti
RN closure Cap, H0, Ti (4-pack)
RC Healing Abutment, conical diameter 6, H6
NNC Closure Screw, H0.5
RC Healing Abutment, conical diameter 6, H4
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility