FDA.reportPublic FDA data

Luxisse+

Primary DI
00817724021842
Brand
Luxisse+
Company
HEANY INDUSTRIES, INC.
Model
0
Catalog number
MDCY0669ZSCD3
Device description
YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
Published
2017-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150056000Luxisse+Heany Industries, Inc.2015-05-06EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817724021842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817724021842008177240218428177240218420817724021842

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter17Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5858892700cliffr@heany.com

Regulatory Flags#

DUNS number
002221091
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817724029039Luxisse0MDDK3702ZF30B12023-08-07
00817724029022Luxisse0MDDK3701ZF10B22023-07-31
00817724028995LUXISSEBMD DK 0639 002022-11-01
00817724029008LUXISSEBMD DK 0639 202022-11-01
00817724029015LUXISSEBMD DK 0639 302022-11-01
00817724028933LUXISSE0MDDK3701ZF10A352022-10-24
00817724028940LUXISSE0MDDK3701ZF10A42022-10-24
00817724028957LUXISSE0MDDK3701ZF10C12022-10-24
00817724028964LUXISSE0MDDK3701ZF10C32022-10-24
00817724028971LUXISSE0MDDK3701ZF10C42022-10-24
00817724028988LUXISSE0MDDK3701ZF10D42022-10-24
00817724028926LUXISSEBMD DK 0639 012022-04-27
00817724028919LUXISSEEMDDK3702ZF30OM32022-02-28
00817724028865Luxisse0MDDK3701ZF10A32022-01-31
00817724028872Luxisse0MDDK3701ZF10B12022-01-31
00817724028889LUXISSE0MDDK3701ZF10C22022-01-31
00817724028896LUXISSE0MDDK3701ZF10D22022-01-31
00817724028902Luxisse0MDDK3701ZF10D32022-01-31
00817724028841Luxisse0MDDK3701ZF10A22021-03-23
00817724028834Luxisse0MDDK3701ZF10A12021-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EDMC32623024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
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EDMC32713087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
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EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16