Light, Fiber Optic, Dental

Product Code: EAY

Dental General Optical Products / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 872.4620

• Radiation Type: Optical
• Radition Safety: None
• Annual Reports: No

Products Classified as EAY

1115

Light, Fiber Optic, Dental

Fiber Optic Dental Light.

Total Product Life Cycle (TPLC) Devices

1115

Light, Fiber Optic, Dental

Fiber Optic Dental Light.

Pre-market Notifications for EAY

K953191	MODEL A15-101	BEAVERSTATE DENTAL, INC.
K953192	MODEL A15-103	BEAVERSTATE DENTAL, INC.
K935718	JEDENTAL VLC DENTAL CURING LIGHT	JEDENTAL CO., INC.
K831976	POWER OPTIC	RITTER CO.
K820907	DENTISCOPE	CHAYES VIRGINIA, INC.
K812605	FIBER OPTIC LIGHT SOURCE I	VENTURE TECHNOLOGY, INC.
K802716	DEN-MAT FIBER OPTIC HALOGEN LIGHT	DEN-MAT CORP.
K802684	HELIOMAT	VIVADENT (USA), INC.
K801592	FIBER OPTIC HOSE	LARES MANUFACTURING CO., INC.
K801591	FIBER OPTIC ILLUMINATOR	LARES MANUFACTURING CO., INC.
K791771	ORALUMINATOR III AUTO-LIGHT	MIDWEST
K791733	LIGHT-PAK	MIDWEST
K781878	LIGHT, INSIDE	MIDWEST
K760795	FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C.	MIDWEST
K760796	ORALUMINATOR III - LIGHT SOURCE FOR F.O.	MIDWEST

Global Unique Device Identification Database

• D798LEDPS0: Light, Fiber Optic, Dental
• D798LEDBAT0: Light, Fiber Optic, Dental
• 00889024134508: LIGHT, FIBER OPTIC, DENTAL
• 00889024134492: LIGHT, FIBER OPTIC, DENTAL
• 00889024134485: LIGHT, FIBER OPTIC, DENTAL
• 00889024134478: LIGHT, FIBER OPTIC, DENTAL
• 00889024134317: LIGHT, FIBER OPTIC, DENTAL
• 00889024133396: LIGHT, FIBER OPTIC, DENTAL
• 04560218680945: Light, Fiber Optic, Dental
• D836PSLFH9: Light, Fiber Optic, Dental
• D2483550891: LIGHT, FIBER OPTIC, DENTAL
• D2483550881: LIGHT, FIBER OPTIC, DENTAL
• D2483550871: LIGHT, FIBER OPTIC, DENTAL
• D2483550861: LIGHT, FIBER OPTIC, DENTAL
• 04719883751355: Light, Fiber Optic, Dental

Maude Adverse Events

ISOLITE SYSTEM MOUTHPIECE	INNERLITE, INC., DBA ISOLITE SYSTEMS	2013-10-16
QHL75CURING LIGHT	L.D. CAULK	2001-05-14
ELIPAR HIGHLIGHT	ESPE DENTAL-MEDIZIN GMBH & CO.KG.	1998-07-08
COLTOLUX CURING LIGHT	COLTENE/WHALDENT INC.	1997-02-14