FDA Registration
Active
🇮🇱 Israel
ZIRCON PLUS LIMITED
Reg #: 3026400121
·
FEI: 3026400121
·
Expires 2026
Products
11
Proprietary Names
0
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- ZIRCON PLUS LIMITED
- Registration Number
- 3026400121
- FEI Number
- 3026400121
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MENDEL MATITYAHU 7, Suite 1
- City
- Ramat Gan Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K070325
Owner / Operator
- Firm Name
- ZIRCON PLUS LIMITED
- Operator Number
- 10087265
- Address
- MENDEL MATITYAHU 7, Suite 1
- City
- Ramat Gan
- State
- Central
- Postal Code
- 528704
- Country
- IL
- Correspondent
- Jill Kalfa
US Agent
- Business Name
- Zeek Logistics
- Contact Name
- Jill Kalfa
- Address
- 2709 N. Rolling Rd., #138
- City
- Baltimore
- State
- MD
- ZIP
- 21244
- Country
- US
- [email protected]
- Phone
- 914 3364627
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2025-11-15 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-11-15 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2025-11-15 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2023-02-06 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2025-11-15 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2025-11-15 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2025-11-15 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2025-11-15 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2025-11-15 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-11-15 |
| Material, Impression | ELW | Class 2 | Dental | No | 2025-11-15 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device