Data / Medical devices / United States / Angstrom MFG., Inc.
Angstrom MFG., Inc.: FDA-registered device maker in Sainte Genevieve, MO, United States, 4 510(k) clearances
Angstrom MFG., Inc. is registered with the FDA (registration 3003610374) in Sainte Genevieve, MO, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003610374
- Address
- 4 Trautman Industrial Court, Sainte Genevieve, MO, United States, 63670
- Owner or operator
- ANGSTROM MFG., INC. (9041999)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 3, 2012
- Registered through
- 2026
- Brand names listed
- BRS Level 1 Procedure Face Mask 081-00-1016, BRS Level 2 Procedure Face Mask 081-00-1018, BRS Level 3 Procedure Face Mask 3-Layer, BRS Level 3 Procedure Face Mask 4-Layer 081-00-1020, BRS Metal Free Level 1 Procedure Face Mask 081-00-1015, BRS Metal Free Level 2 Procedure Face Mask, Fluid Resistant Procedure Face Mask with Earloops, Prophy Angle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Evacuator, Oral Cavity | EHZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Contract manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2021 | K202824 | BRS Procedure Face Mask | FXX | Substantially Equivalent | Blackbriar Regulatory Services, LLC | accessdata.fda.gov |
| February 7, 2011 | K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | EGS | Substantially Equivalent | Angstrom Mfg., Inc. | accessdata.fda.gov |
| January 24, 2011 | K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Angstrom Mfg., Inc. | accessdata.fda.gov |
| May 27, 1993 | K923980 | Q3 DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Q3 Special Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Powered Laser Surgical Instrument
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Mask, Surgical
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Evacuator, Oral Cavity
Updated March 25, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.