FDA Registration
Active
🇯🇵 Japan
DENTECH CORP.
Reg #: 9611450
·
FEI: 3002809535
·
Expires 2026
Products
23
Proprietary Names
13
Establishment Types
3
Classifications
23
Registration Details
- Registration Name
- DENTECH CORP.
- Registration Number
- 9611450
- FEI Number
- 3002809535
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 53 SHIMIZU-CHO, ITABASHI-KU
- City
- TOKYO
- Country
- JP
Owner / Operator
- Firm Name
- DENTECH CORP.
- Operator Number
- 8030336
- Address
- 53 SHIMIZU-CHO, ITABASHI-KU, --
- City
- TOKYO
- State
- JP-NOTA
- Postal Code
- 174-0053
- Country
- JP
- Correspondent
- DAISUKE - KIMURA
US Agent
- Business Name
- HAGER WORLDWIDE, INC.
- Contact Name
- Donna Pritchard
- Address
- 441 19TH STREET SE, HAGER WORLDWIDE, INC.
- City
- Hickory
- State
- NC
- ZIP
- 28602
- Country
- US
- [email protected]
- Phone
- 828 6243319
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2016-06-08 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 1998-06-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-09-12 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 1981-08-15 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2019-09-12 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2019-09-12 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2019-09-12 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2019-09-12 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 1981-08-15 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 1983-09-27 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 1981-08-15 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 1998-05-21 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 1981-08-15 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 2019-09-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2019-09-12 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2016-06-08 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1983-09-27 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 1981-08-15 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2019-09-12 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 1998-05-21 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 1981-08-15 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1981-08-15 |
| Instrument, Contouring, Matrix, Operative | EKF | Class 1 | Dental | No | 2019-09-12 |
Proprietary Names
Dentech Corporation
MIRALAY
MOUTHPIECE, SALIVA EJECTOR
FORCEPS, RUBBER DAM
FORCEPS, ARTICULATION PAPER
FRAME, RUBBER DAM
ACCESSORIES, RETRACTOR, DENTAL
CLAMP, RUBBER DAM
BUR, DENTAL
INSTRUMENTS, DENTAL HAND
METAL MIRROR
RETAINER, MATRIX
FORCEPS, RONGEUR, SURGICAL
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device