FDA.reportPublic FDA data

Illuminate

Primary DI
00190707041229
Brand
Illuminate
Company
Ortho Organizers, Inc.
Model
471-050
Device description
ILLUMINATE LIGHT-CURE ADHESIVE KIT
Published
2019-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935625000ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDEWallace A. Erickson & Co.1994-08-10DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707041229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707041229001907070412291907070412290190707041229

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707195014Retainer Wire682932026-10-20
00190707133207Band Assemblies900-123061E-0202025-07-07
00190707134341Band Assemblies900-124061E-0202025-07-07
00190707140021Band Assemblies900-103061E-032025-07-07
00190707140366Band Assemblies900-104061E-032025-07-07
00190707141387Band Assemblies900-123061E-032025-07-07
00190707141516Band Assemblies900-124061E-032025-07-07
00190707192976Aria® Expressions®716-303CH-102026-08-27
00190707192983Aria® Expressions®716-304CH-102026-08-27
00190707192990Aria® Expressions®716-321CH-102026-08-27
00190707193003Aria® Expressions®716-322CH-102026-08-27
00190707193010Aria® Expressions®716-333CH-102026-08-27
00190707193027Aria® Expressions®716-351CH-HK-102026-08-27
00190707193034Aria® Expressions®716-352CH-HK-102026-08-27
00190707193041Aria® Expressions®716-359CH-HK-102026-08-27
00190707193058Aria® Expressions®716-360CH-HK-102026-08-27
00190707193065Aria® Expressions®716-369CH-HK-102026-08-27
00190707193072Aria® Expressions®716-370CH-HK-102026-08-27
00190707193089Aria® Expressions®716-389CH-HK-102026-08-27
00190707193096Aria® Expressions®716-390CH-HK-102026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062605SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062612SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062629SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062636SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062643SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062650SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062667SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062674SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062766SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062773SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062780SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062797SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062865SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062872SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062896SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064739SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064746SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067891SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067907SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067914SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067921SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067938SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067945SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067952SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067969SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067976SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067983SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069208SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069215SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069222SolventumSolventum Orthodontics CorporationDYH2026-11-04