Manufacturer registered with FDA
OPCOM Inc.
New Taipei City, Taiwan. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Taiwan
Devices listed with FDA
What OPCOM 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Duck MIRROR, MOUTH | 2024 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | Duck Plus TEETH, ARTIFICIAL, BACKING AND FACING | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OPCOM INC.FDA reg. 3000279801 | New Taipei City, Taiwan | Contract manufacturer, Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084244). 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.