FDA Registration
Active
🇩🇪 Germany
110.2332 - SURGmatic S201 XL
Reg #: 3003637274
·
FEI: 3003637274
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KAVO DENTAL GMBH
- Registration Number
- 3003637274
- FEI Number
- 3003637274
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BAHNHOFSTRASSE 20
- City
- WARTHAUSEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K140308
Owner / Operator
- Firm Name
- KaVo Dental GmbH
- Operator Number
- 10042139
- Address
- Bismarckring 39
- City
- Biberach
- State
- Baden-Wurttemberg
- Postal Code
- 88400
- Country
- DE
US Agent
- Business Name
- KaVo Dental Technologies, LLC
- Contact Name
- Crystal Bialek
- Address
- 11727 Fruehauf Drive
- City
- Charlotte
- State
- NC
- ZIP
- 28273
- Country
- US
- [email protected]
- Phone
- 704 2886058
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2014-08-18 |
Proprietary Names
110.2332 - SURGmatic S201 XL
109.1200 - MASTERsurg LUX
109.8757 - Tube Set S600
108.3500 - EXPERTsurg LUX
109.1005 - SURGmatic S11 C
110.2333 - SURGmatic S201 XC
109.1100 - SURGmatic S201 C
109.1010 - SURGmatic S11 L
108.8000 - INTRA LUX S600 LED
109470 - SURGmatic S201 L
111.4900 - SM5
110.9726 - Demo Unit MASTERsurg LUX
110.8042 - Demo Unit EXPERTsurg LUX
113.7541 - SURGmatic S201 XL Pro
113.7540 - SURGmatic S201 L Pro
113.8648 - SURGmatic Head S201 L Pro
113.8662 - SURGmatic Head S201 XL Pro
Establishment Types
Manufacture Medical Device