Manufacturer registered with FDA
Angstrom Mfg., Inc.
Sainte Genevieve, MO, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 2
- 510(k) clearances
- 22011–2011
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Angstrom Mfg., Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Prophy Angle | 2012 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | — | 2018 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Prophy Angle | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Angstrom Mfg., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Feb 2011 | K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 24 Jan 2011 | K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Also lists devices cleared under other names
Angstrom Mfg., Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Q3 Special Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 May 1993 | K923980 | Q3 DISPOSABLE PROPHY ANGLE | Q3 Special Products, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ANGSTROM MFG., INC.FDA reg. 3003610374 | Sainte Genevieve, MO, United States | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9041999). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.