FDA Registration
Active
🇰🇷 South Korea
MCTBIO
Reg #: 3008388427
·
FEI: 3008388427
·
Expires 2026
Products
20
Proprietary Names
32
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- MCTBIO
- Registration Number
- 3008388427
- FEI Number
- 3008388427
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 46 Chobu-ro, Mohyeon-myeon, Cheoin-gu
- City
- Yongin-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- MCTBIO
- Operator Number
- 10032614
- Address
- 46 Chobu-ro, Mohyeon-myeon, Cheoin-gu
- City
- Yongin-si
- State
- Gyeonggi
- Postal Code
- 17037
- Country
- KR
- Correspondent
- Sungyoun Kim
US Agent
- Business Name
- K B DENTAL PRODUCTS
- Contact Name
- KEVIN Bang
- Address
- 1205 N Tustin Ave
- City
- Anaheim
- State
- CA
- ZIP
- 92807
- Country
- US
- [email protected]
- Phone
- 714 5915851
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2012-07-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2010-05-31 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2014-02-12 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2012-07-12 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2010-05-31 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2010-05-31 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2010-05-31 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2010-05-31 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2010-05-31 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2010-05-31 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2017-02-08 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2010-06-01 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2010-05-31 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2010-05-31 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2013-01-15 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2010-05-31 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 2010-05-31 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-07-09 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2010-05-31 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2010-05-31 |
Proprietary Names
DENTAL IMPLANT DRILL
Bone Rongeur/ Forcep/ Retractor
BONE TAC
ORTHODONTIC SCREW
SMART MIXER
SCALE/Excavator
Periotome/ Peiosteal Elevator/ Bone Curette/Gracey Curette/Scaler
SCISSORS
SPLIT & SINUS MASTER
BONE EXPANDER
ACCESSORIES, IMPLANT
MASAI DRILL
PREMIUM RIDGE SPLIT KIT
GOLD MILL
Screw Remover
Fixture Remover
AQUA SYSTEM
BONE CREST MASTER
New Bone Chip Maker
INSTRUMENT/ DENTAL
STAR JECT ENDO
STAR JECT
IRRIGATION SYSTEM
Mallet
MIRROR/ Mouth
PRF-BOX
FORCEPS
SUCTION
2875 MASK
SONA GUARD
RULERS AND CALIPERS
GAUGE
Establishment Types
Manufacture Medical Device