FDA Registration
Active
🇨🇭 Switzerland
SAREMCO DENTAL AG
Reg #: 3008582054
·
FEI: 3008582054
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- SAREMCO DENTAL AG
- Registration Number
- 3008582054
- FEI Number
- 3008582054
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Gewerbestrasse 4
- City
- 9445 Rebstein Sankt Gallen
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K213343
Owner / Operator
- Firm Name
- Saremco Dental AG
- Operator Number
- 10084365
- Address
- Gewerbestrasse 4
- City
- Rebstein
- State
- CH-NOTA
- Postal Code
- 9445
- Country
- CH
- Correspondent
- Sven Hauser
US Agent
- Business Name
- BQC Consulting, LLC
- Contact Name
- Nevine Erian
- Address
- 24341 Barbados Dr.
- City
- Dana Point
- State
- CA
- ZIP
- 92629
- Country
- US
- [email protected]
- Phone
- 949 3707155
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-02-14 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2022-02-14 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2022-02-14 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2026-01-21 |
Proprietary Names
saremco print Crowntec
els extra low shrinkage® composite
els unibond
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198