FDA Registration
Active
🇮🇱 Israel
Q-TEMP
Reg #: 1000272892
·
FEI: 1000272892
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- B.J.M. LABORATORIES LTD
- Registration Number
- 1000272892
- FEI Number
- 1000272892
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12 HASADNA ST., INDUSTRIAL PARK
- City
- OR-YEHUDA Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K051866
Owner / Operator
- Firm Name
- B.J.M. Laboratories Ltd
- Operator Number
- 9057695
- Address
- 12 Hasadna Street, Industrial Park
- City
- Or-Yehuda
- State
- Central
- Postal Code
- 6022011
- Country
- IL
- Correspondent
- Barry N Zalsman
US Agent
- Business Name
- Premier Dental Products Company
- Contact Name
- Jessica Huang
- Address
- 1710 Romano Drive
- City
- Plymouth Meeting
- State
- PA
- ZIP
- 19462
- Country
- US
- [email protected]
- Phone
- 610 2396015 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2012-11-14 |
Proprietary Names
Q-TEMP
PREMIER NEXTEMP TEMPORARY CEMENT
Establishment Types
Manufacture Medical Device