FDA Registration
Active
🇺🇸 United States
DenMat Bulk Fill; Evanesce Bulk Fill
Reg #: 3010419931
·
FEI: 3010419931
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIGNA MEDICAL, INC.
- Registration Number
- 3010419931
- FEI Number
- 3010419931
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 100 West Broadway, Suite 7Y
- City
- Long Beach
- State
- NY
- ZIP
- 11561
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242097
Owner / Operator
- Firm Name
- Signa Medical, Inc.
- Operator Number
- 10045410
- Address
- 100 West Broadway, Suite 7Y
- City
- Long Beach
- State
- NY
- Postal Code
- 11561
- Country
- US
- Correspondent
- Alex Kleiman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-01-10 |
Proprietary Names
DenMat Bulk Fill; Evanesce Bulk Fill
Establishment Types
Repack or Relabel Medical Device