FDA Registration
Active
🇺🇸 United States
3rd Generation Affinity Hydroactive Impression Material
Reg #: 2018957
·
FEI: 2018957
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DEN-MAT HOLDINGS, LLC
- Registration Number
- 2018957
- FEI Number
- 2018957
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1017 W Central Ave
- City
- Lompoc
- State
- CA
- ZIP
- 93436
- Country
- US
Regulatory Submissions
- 510(k) Number
- K053014
Owner / Operator
- Firm Name
- DEN-MAT HOLDINGS, LLC
- Operator Number
- 2018957
- Address
- 1017 W. CENTRAL AVENUE, --
- City
- Lompoc
- State
- CA
- Postal Code
- 93436
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2024-12-03 |
Proprietary Names
3rd Generation Affinity Hydroactive Impression Material
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device