FDA Registration
Active
🇰🇷 South Korea
META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd
Reg #: 3007663058
·
FEI: 3007663058
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd
- Registration Number
- 3007663058
- FEI Number
- 3007663058
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K253461
Owner / Operator
- Firm Name
- Meta Biomed, Inc
- Operator Number
- 10029431
- Address
- 3015 ADVANCE LANE
- City
- Colmar
- State
- PA
- Postal Code
- 18915
- Country
- US
- Correspondent
- Ian Yun
US Agent
- Business Name
- META BIOMED, INC
- Contact Name
- Ian Yun
- Address
- 3015 Advance Lane
- City
- Colmar
- State
- PA
- ZIP
- 18915
- Country
- US
- [email protected]
- Phone
- 267 2825893
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gutta-Percha | EKM | Class 1 | Dental | No | 2015-10-28 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2025-11-15 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2022-09-22 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2022-09-22 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2018-07-30 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2015-11-09 |
Proprietary Names
GUTTA PERCHA CARTRIDGE
EQ-M
i-ROOT 100 mini
EQ-S
EQ-PEX
EQ-V
EQ Condenser
Establishment Types
Manufacture Medical Device