Surgical devices · 21 CFR 872 Subpart E
Dental Fiber Optic Light
FDA device type “Light, Fiber Optic, Dental”.
- Companies listing it
- 2313 makers
- Brands and models
- 23
- 510(k) clearances
- 180 in five years
- FDA name
- Light, Fiber Optic, Dental
510(k) clearances per year, 1976–2026
Companies that list EAY
23 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | Light Guides for Curing Lights | 203 | 2026 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Fiber optic/Dental delivery unit | 2 | 2026 |
| Zimmer Inc | United States | Maker | LIGHT CABLE | 14 | 2001 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | Light, fiber Optic, Dental | 5 | 2007 |
| Dentech Corp. | Japan | Maker | Dentech Corporation | — | — |
| Dhef Inc. | Taiwan | Maker | FIBER OPTIC · LIGHT | — | — |
| 麦迪卡有限公司 MedicNRG Ltd | Israel | Maker | LIGHT, FIBER OPTIC, DENTAL · LumiNRG | — | — |
| Endonest Medical Systems LLP | India | Maker | Light, Fiber Optic, EndoNest FOC, EndoNest Lights , EndoNest Cables , EndoNest All Type Cables | — | — |
| Dntlworks Equipment Corp. | United States | Maker | DNTLworks ProBrite | — | — |
| Quality Aspirators | United States | Maker | Fiber Optic Light | — | — |
| Denbur Inc | United States | Maker | Light-Tip | — | — |
| Kmi Imi Group / Dba Innovative Med, Inc. | United States | Maker | THERAGLOW SMILE MACHINE | — | — |
| Alira Medical Devices LLC | United States | Maker | LIGHT, FIBER OPTIC, DENTAL | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | POWER SLOT | 32 | 2021 |
| Dent Zar, Inc. | United States | Repacker / relabeler | DENTAL CURING LIGHT | 12 | 1996 |
| Dentamerica | United States | Repacker / relabeler | LITEX | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Fiber Optic System | 3 | 2007 |
| Hager Worldwide, Inc. | United States | Manufacturer | — | 2 | 2005 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | FIBER OPTIC · LIGHT | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Optic Light | — | — |
| INVIDIA Medical GmbH u CO KG | Germany | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 Sep 1995 | K953192 | MODEL A15-103 | Beaverstate Dental, Inc. |
| 5 Sep 1995 | K953191 | MODEL A15-101 | Beaverstate Dental, Inc. |
| 26 Jan 1994 | K935718 | JEDENTAL VLC DENTAL CURING LIGHT | Jedental Co., Inc. |
| 3 Aug 1987 | K871816 | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | Stryker |
| 12 Aug 1983 | K831976 | POWER OPTIC | Ritter Co. |
| 11 Aug 1983 | K831824 | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Silverman'S |
| 5 May 1982 | K820907 | DENTISCOPE | Chayes Virginia, Inc. |
| 2 Oct 1981 | K812605 | FIBER OPTIC LIGHT SOURCE I | Venture Technology, Inc. |
| 24 Nov 1980 | K802684 | HELIOMAT | Vivadent (Usa), Inc. |
| 12 Nov 1980 | K802716 | DEN-MAT FIBER OPTIC HALOGEN LIGHT | Den-Mat Corp. |
| 21 Jul 1980 | K801592 | FIBER OPTIC HOSE | Lares Manufacturing Co., Inc. |
| 21 Jul 1980 | K801591 | FIBER OPTIC ILLUMINATOR | Lares Manufacturing Co., Inc. |
| 20 Nov 1979 | K791771 | ORALUMINATOR III AUTO-LIGHT | Midwest |
| 23 Oct 1979 | K791733 | LIGHT-PAK | Midwest |
| 29 Dec 1978 | K781878 | LIGHT, INSIDE | Midwest |
| 3 Jan 1977 | K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | Syntex Corp. |
| 20 Oct 1976 | K760796 | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | Midwest |
| 20 Oct 1976 | K760795 | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | Midwest |
Official records: FDA product classification for EAY · 21 CFR 872.4620.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026