FDA.reportPublic FDA data

LED dental light, battery-powered

Definition
A battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.
GUDID devices
47
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810186670009Enova IlluminationEnova Illumination, Inc.8000702025-01-16
07630392901437Coltolux ComfortDent4You AG600343932023-02-01
07630392901444Coltolux ComfortDent4You AG600343942023-02-01
07630392901451Coltolux ComfortDent4You AG600343952023-02-01
07630392901468Coltolux ComfortDent4You AG600343962023-02-01
B366LED0203PORTALEDEclerisR002025-11-21
B366LED0204R00PORTALEDEclerisR002026-02-11
B366LED0204PORTALEDEclerisRX12026-01-23
03760405340282LED AdapterDENTAL MONITORINGLED Adapter2025-12-17
00810186670146Enova IlluminationEnova Illumination, Inc.80801-0012025-12-10
B366LED0202PICO LEDEclerisRX12025-01-27
00813557020120LuMDigital Doc LLCLuM-10002025-01-21
00813557020151LuMDigital Doc LLCLuM-30002025-01-21
D813ALED41INT0PeriOptixDEN-MAT HOLDINGS, LLCA-LED4-2-INT2024-09-19
D813ALED420PeriOptixDEN-MAT HOLDINGS, LLCA-LED4-22024-09-19
D813ALED5990PeriOptixDEN-MAT HOLDINGS, LLCA-LED5-992024-09-19
D813ALED599B0PeriOptixDEN-MAT HOLDINGS, LLCA-LED5-99B2024-09-19
D813ALED599R0PeriOptixDEN-MAT HOLDINGS, LLCA-LED5-99R2024-09-19
D813ALED6990PeriOptixDEN-MAT HOLDINGS, LLCA-LED6-992024-09-19
D2483550861FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.3550862023-05-12
D2483550871FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.3550872023-05-12
D2483550881FOCU-TIP NO.9 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.3550882023-05-12
D2483550891FOCU-TIP NO.12 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.3550892023-05-12
07630392901406Coltolux ComfortDent4You AG600343902023-02-01
07630392901413Coltolux ComfortDent4You AG600343912023-02-01
07630392901420Coltolux ComfortDent4You AG600343922023-02-01
07630392903417Coltolux ComfortDent4You AG600344462023-02-01
17630392901434Coltolux ComfortDent4You AG600343932023-02-01
17630392901441Coltolux ComfortDent4You AG600343942023-02-01
17630392901458Coltolux ComfortDent4You AG600343952023-02-01
17630392901465Coltolux ComfortDent4You AG600343962023-02-01
00887919933373Brasseler USAPeter Brasseler Holdings, LLC5029550U02022-12-07
00887919933403Brasseler USAPeter Brasseler Holdings, LLC5029551U02022-12-07
D813200POPTIX0PeriOptix®DEN-MAT HOLDINGS, LLC200POPTIX2022-09-22
D813ALED50PeriOptix®DEN-MAT HOLDINGS, LLCA-LED52022-09-22
D813ALED5B0PeriOptix®DEN-MAT HOLDINGS, LLCA-LED5B2022-09-22
D813ALED5R0PeriOptix®DEN-MAT HOLDINGS, LLCA-LED5R2022-09-22
D813ALED60PeriOptix®DEN-MAT HOLDINGS, LLCA-LED62022-09-22
D813AREPKITNA0PeriOptix®DEN-MAT HOLDINGS, LLCA-REPKIT-NA2022-09-22
D813LPMM0PeriOptix®DEN-MAT HOLDINGS, LLCL-PPM2022-09-22
B366LED020PORTALEDEclerisR002022-05-09
00850025993289Enova IlluminationEnova Illumination, Inc.8000612022-01-26
00850025993319Enova IlluminationEnova Illumination, Inc.8000602022-01-27
04560218680945DENTECHDENTECH CORPORATION300803502020-09-24
00766054002857Endo CSVESSENTIAL DENTAL SYSTEMS, INC.5100-LED2020-07-17
D798LEDBAT0LED BatteryRELIANCE ORTHODONTIC PRODUCTS INCLEDBAT2016-09-20
D798UVBAT0UV Minilight BatteryRELIANCE ORTHODONTIC PRODUCTS INCUVBAT2016-09-20