FDA Registration
Active
🇺🇸 United States
ANGSTROM MFG., INC.
Reg #: 3003610374
·
FEI: 3003610374
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ANGSTROM MFG., INC.
- Registration Number
- 3003610374
- FEI Number
- 3003610374
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4 Trautman Industrial Court
- City
- Sainte Genevieve
- State
- MO
- ZIP
- 63670
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103158
Owner / Operator
- Firm Name
- ANGSTROM MFG., INC.
- Operator Number
- 9041999
- Address
- 4 Trautman Industrial Court, --
- City
- Sainte Genevieve
- State
- MO
- Postal Code
- 63670
- Country
- US
- Correspondent
- CHRIS J CARRON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-04-28 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2014-04-03 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-10-11 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2016-12-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-02-08 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2018-07-12 |
Proprietary Names
Prophy Angle
Fluid Resistant Procedure Face Mask with Earloops
BRS Level 3 Procedure Face Mask 3-Layer
BRS Level 1 Procedure Face Mask 081-00-1016
BRS Level 2 Procedure Face Mask 081-00-1018
BRS Metal Free Level 1 Procedure Face Mask 081-00-1015
BRS Metal Free Level 2 Procedure Face Mask
BRS Level 3 Procedure Face Mask 4-Layer 081-00-1020
prophy angle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device