FDA Registration
Active
🇨🇭 Switzerland
MAILLEFER INSTRUMENTS HOLDING SARL
Reg #: 8031010
·
FEI: 1000185904
·
Expires 2026
Products
32
Proprietary Names
12
Establishment Types
5
Classifications
32
Registration Details
- Registration Name
- MAILLEFER INSTRUMENTS HOLDING SARL
- Registration Number
- 8031010
- FEI Number
- 1000185904
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CH. DU VERGER 3
- City
- BALLAIGUES Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K121206
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
US Agent
- Business Name
- DENTSPLY SIRONA INC
- Contact Name
- Dan Eagar
- Address
- 13320 Ballantyne Corp Pl
- City
- Charlotte
- State
- NC
- ZIP
- 28277
- Country
- US
- [email protected]
- Phone
- 704 4926977
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 1977-12-15 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1998-09-08 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1997-06-27 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2024-05-28 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2013-01-04 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2026-06-11 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 1989-01-27 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 1984-11-16 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 1977-12-15 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2006-10-26 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2015-12-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-04 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2013-01-04 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2013-01-04 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2013-01-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-04 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 1997-02-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-04 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 1996-08-21 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2013-01-04 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2013-01-04 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 1984-11-16 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 1995-03-27 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 1992-08-24 |
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2026-06-12 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2001-10-23 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 1996-08-21 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 1995-08-11 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 1998-09-08 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1992-08-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-04 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 1997-06-27 |
Proprietary Names
Drill single patient use
tack drills
EMERGENCE PROFILE
Bracket Height Gauge
Drills
GATES
LARGO
MONO Surgery Kit
Caulk Post & Core Kit
Paper Points
Zircon diamond burr set
Dental Tools
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device