FDA Registration
Active
🇰🇷 South Korea
ZAPALIGN INC.
Reg #: 3011944170
·
FEI: 3011944170
·
Expires 2026
Products
16
Proprietary Names
9
Establishment Types
1
Classifications
16
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Registration Details
- Registration Name
- ZAPALIGN INC.
- Registration Number
- 3011944170
- FEI Number
- 3011944170
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #1004, 10F, 181, Simin-daero, Dongan-gu,
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K960787
Owner / Operator
- Firm Name
- Zapalign Inc.
- Operator Number
- 10091758
- Address
- B-1001, U-space2, 670, Daewangpangyo-ro, Bundang-gu,
- City
- Seongnam-si,
- State
- Gyeonggi
- Postal Code
- 13494
- Country
- KR
- Correspondent
- ByeongGeon Song
US Agent
- Business Name
- Zapalign LLC
- Contact Name
- Marty Trabish
- Address
- 2281 Griffin Rd
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33312
- Country
- US
- [email protected]
- Phone
- 786 4793208
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2026-04-01 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-04-23 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2025-06-12 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2026-06-08 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2026-04-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-04-07 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2025-05-28 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2026-04-01 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-06-12 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2026-05-04 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2026-05-04 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2025-05-28 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2026-04-01 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2025-06-12 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2024-10-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-04-28 |
Proprietary Names
MIXEVAC CEMENT MIXERS
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
PROVI CEMENT
COLORADO MICRO DISSECTION NEEDLE
SYSTEM, SKIN CLOSURE
ZINC OXIDE EUGENOL
Cavitron
Blade, Saw, General & Plastic Surgery, Surgical
SUGICAL NEOPRENE GLOVE (NON-LATEX)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device