FDA.reportPublic FDA data

ViziLite®

Primary DI
D8136501991
Brand
ViziLite®
Company
DEN-MAT HOLDINGS, LLC
Model
650199
Catalog number
650199
Device description
VIZILITE PLUS TBULE EXAM 10 PACK
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAZLight, Operating, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033033000VIZILITE-BLUE ORAL EXAM KITTrylon Corp.2004-11-22EAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8136501991PrimaryHIBCC0
D8136501990Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oral lesion examination lightA battery-powered, hand-held, torch-like device designed to visualize, and facilitate identification of, abnormalities of the oral mucosa (e.g., malignancy, dysplasia, bacterial and fungal infections) using one or more wavelengths (colours) of light. It may be supplied with disposable accessories (e.g., mirrors, tinted spectacles, lens covers). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D813CR11010Nuance®CR1101CR11012016-09-24
D813CR11020Nuance®CR1102CR11022016-09-24
D813CR11030Nuance®CR1103CR11032016-09-24
D813CR11040Nuance®CR1104CR11042016-09-24
D813CR11060Nuance®CR1106CR11062016-09-24
D813CR11080Nuance®CR1108CR11082016-09-24
D813CR11120Nuance®CR1112CR11122016-09-24
D813CR11210Nuance®CR1121CR11212016-09-24
D813CR11350Nuance®CR1135CR11352016-09-24
D813CR11360Nuance®CR1136CR11362016-09-24
D813CR11370Nuance®CR1137CR11372016-09-24
D813CR11380Nuance®CR1138CR11382016-09-24
D813CR11400Nuance®CR1140CR11402016-09-24
D813CR11420Nuance®CR1142CR11422016-09-24
D813CR11430Nuance®CR1143CR11432016-09-24
D813CR11460Nuance®CR1146CR11462016-09-24
D813CR11550Nuance®CR1155CR11552016-09-24
D813CR12090Nuance®CR1209CR12092016-09-24
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719965090020LED Operating LightCHUAN FU MEDICAL INSTRUMENT CO., LTD.EAZ2026-10-22
08033837933021CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837933045CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938583CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938606CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938644CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938682CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938699CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938705CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938712CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938729CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938736CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938743CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
00841709125638MidmarkMIDMARK CORPORATIONEAZ2026-07-08
00840456221372JMUJMU DENTAL, INCEAZ2026-07-06
00840456221389JMUJMU DENTAL, INCEAZ2026-07-06
00840456221396JMUJMU DENTAL, INCEAZ2026-07-06
00840456221402JMUJMU DENTAL, INCEAZ2026-07-06
00840456221419JMUJMU DENTAL, INCEAZ2026-07-06
00840456221426JMUJMU DENTAL, INCEAZ2026-07-06
00841709121920MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122088MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122217MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709121906MidmarkMIDMARK CORPORATIONEAZ2026-03-18
00841709121913MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121937MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121944MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121951MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121968MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121975MidmarkMIDMARK CORPORATIONEAZ2026-03-10