Data / Medical devices / Light, Fiber Optic, Dental
Light, Fiber Optic, Dental (EAY): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Light, Fiber Optic, Dental (product code EAY, Class 1, 21 CFR 872.4620). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on September 5, 1995, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- EAY
- Device class
- 1
- Regulation
- 872.4620
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Taiwan | 2 |
| Japan | 1 |
| India | 1 |
| China | 1 |
| Israel | 1 |
| Mexico | 1 |
Makers of Light, Fiber Optic, Dental
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alira Medical Devices LLC | Rancho Cucamonga, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apoza Enterprise Co., Ltd. | Hsin-Chuang District New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denbur, Inc. | Westmont, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentech Corp. | Tokyo, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dntlworks Equipment Corp. | Centennial, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kmi Imi Group / Dba: Innovative Med, Inc. | Irvine, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Diamond Technologies Ltd.- Medicnrg Ltd. | AFULA Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Dallas, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Duncanville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 5, 1995. 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.