FDA.report

Luminesse HF Incisal - Bleach

Primary DI
D7911953B0
Brand
Luminesse HF Incisal - Bleach
Company
TALLADIUM, INC.
Model
1953B
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7911953B0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Regulatory Flags

DUNS number
094430642
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D79119510OFA0Luminesse Zirconia Discs19510-OFA2023-03-28
D79119518OFA0Luminesse Zirconia Discs19518-OFA19518-OFA2023-03-28
D79119530OFA0Luminesse Zirconia Discs19530-OFA19530-OFA2023-03-28
D79110005Tilite Ceramic Alloys - Premium100-52022-11-29
D79110105Tilite Ceramic Alloys - Vita101-52022-11-29
D79110205Tilite Ceramic Alloys - Star102-52022-11-29
D79111105Tilite Ceramic Alloys - Omega111-52022-11-29
D791CLOFADG0Color Liquid252302022-11-17
D791CLOFADP0Color Liquid252332022-11-17
D791CLOFALG0Color Liquid252292022-11-17
D791CLOFALP0Color Liquid252312022-11-17
D791CLOFAMP0Color Liquid252322022-11-17
D791CLOFAA10OFA Coloring LiquidCL-OFA-A1CL-OFA-A12019-02-21
D791CLOFAKIT0OFA Coloring LiquidCL-OFA-KITCL-OFA-KIT2019-02-20
D7911220Tilite Ceramic Alloys - "S"1221222019-01-28
D7911240Tilite Ceramic Alloys - "O"1241242019-01-28
D7911360Tilite Ceramic Alloys - Gamma Matt1361362019-01-28
D7911954UG0Luminesse Universal Glaze Powder1954-UG1954-UG2019-01-28
D7911955T0Luminesse HF Trial Kit 1955-T1955-T2019-01-28
D791200Tilite Ceramic Alloys - Premium1201202019-01-28

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