FDA Registration
Active
🇨🇭 Switzerland
FKG DENTAIRE SARL
Reg #: 9680913
·
FEI: 3006610063
·
Expires 2026
Products
9
Proprietary Names
57
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- FKG DENTAIRE SARL
- Registration Number
- 9680913
- FEI Number
- 3006610063
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LE CRET-DU-LOCLE 4
- City
- LE CRET-DU-LOCLE Neuchatel
- Country
- CH
Owner / Operator
- Firm Name
- F K G DENTAIRE SARL
- Operator Number
- 9012284
- Address
- LE CRET-DU-LOCLE 4, --
- City
- LE CRET-DU-LOCLE, NE
- State
- Neuchatel
- Postal Code
- CH-2322
- Country
- CH
US Agent
- Business Name
- Brasseler U.S.A. Dental, LLC
- Contact Name
- Nate Thomas
- Address
- 1 Brasseler Blvd
- City
- Savannah
- State
- GA
- ZIP
- 31419
- Country
- US
- [email protected]
- Phone
- 801 4199689
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2023-09-06 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2008-06-02 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2008-06-02 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2008-06-02 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2008-06-02 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2008-06-02 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2022-11-16 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2008-06-02 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2020-12-03 |
Proprietary Names
EndoSequence Scout Files
EndoSequence Orifice Shaper
XP-4D Sequence
RACE
XP-4D Standard
PASTE FILLER LENTULO
XP-3D Shaper +
XP-3D Scout File
EdgeSequel Utopia
FKG
EdgeOne Glidepath
EdgeGlidepath
RazorFlex
ESX
ScoutRace
BC PASTE FILLER
XP-4D Medium
EndoSequence Reciprocating CM Files
Edge X7 Utopia
BT-Race
SENSIPAST
XP-4D Large
XP-4D Assortment
XP-3D Finisher
BioRace
EdgeFile X3
XP-3D Finisher R
XP-4D Starter
EdgeTaper Platinum
XP-3D + PROKIT
EdgeOne Fire
EdgeTaper
EdgeFile X7
EndoSequence CM Taper
EdgeDiamond Utopia
ROOT FILLERS
EndoSequence Rotary Files
EndoSequence CM
EdgeSequel Sapphire
PEESO
PEESO DRILLS
SHORT GATES
GATES
GATES GLIDDEN
BARBED BROACHES
SPREADERS
FINGER SPREADERS
FILES
K-FILES
HEDSTROM
STIFF K-FILES
BROACHES
REAMERS
EndoSequence Hand Files
HEDSTROMS
Apical Verifier
Pluggers
Establishment Types
Manufacture Medical Device