FDA Registration
Active
🇩🇪 Germany
KETTENBACH GMBH & CO KG
Reg #: 9681356
·
FEI: 3006349398
·
Expires 2026
Products
12
Proprietary Names
33
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- KETTENBACH GMBH & CO KG
- Registration Number
- 9681356
- FEI Number
- 3006349398
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- IM HEERFELD 7
- City
- ESCHENBURG Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K191527
Owner / Operator
- Firm Name
- KETTENBACH GMBH & CO KG
- Operator Number
- 9022134
- Address
- IM HEERFELD 7, --
- City
- ESCHENBURG
- State
- Hesse
- Postal Code
- 35713
- Country
- DE
- Correspondent
- Katja - Simon
US Agent
- Business Name
- InterGest North America LLC
- Contact Name
- Wilfried Roggenbau
- Address
- 62 Enter Lane, Bldg. 1
- City
- Islandia
- State
- NY
- ZIP
- 11749
- Country
- US
- [email protected]
- Phone
- 631 5010500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2019-11-13 |
| Material, Impression | ELW | Class 2 | Dental | No | 2008-10-28 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2010-07-02 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2023-02-20 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2023-02-20 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2007-08-22 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2026-06-02 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2013-01-11 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2006-04-10 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2019-11-13 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2009-01-29 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2023-07-25 |
Proprietary Names
Visalys CemCore
Panasil contact (two in one,
Panasil tray (fast, soft)
Panasil putty (putty, putty fast
set, putty soft), Panasil binetics
plus)
(putty fast, putty soft),
Panasil Monophase
Silginat
Silginat Strawberry
Identium Medium Soft,
Identium Light, Identium Medium
Identium Heavy
Materials
Futar (Futar, Futar D,
Futar D Fast, Futar D Slow,
Futar Scan) Bite Registration
Multi Tray
MUCOPREN SOFT RELINING SYSTEM
ProphyProtect
soft fast 1:1, soft fast 5:1)
x-light, X-light fast)
Panasil Initial contact (regular,
Panasil tray (fast 1:1,
regular fast, light, light fast
Visalys Temp
Visalys BioCeramic Block
Mucopren Accessory
Panasil Adhesive
Identium Adhesive
Profisil
Visalys Bulk Fill
Visalys Bulk Flow
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device