FDA.reportPublic FDA data

Luxisse

Primary DI
00817724022511
Brand
Luxisse
Company
HEANY INDUSTRIES, INC.
Model
B
Catalog number
MDDK3937ZF18
Device description
Yttria Stabilized Zirconia
Published
2019-11-05
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817724022511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817724022511008177240225118177240225110817724022511

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 Diameter100Millimeter
Width18Millimeter

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
EYET38800000K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET388000010K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET38800230K2 MyStains ST-S13, uni red, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38800240K2 MyStains ST-S14, uni gingiva, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38780110K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780120K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780210K2 Li-Press-Pellets (HT-Hoch Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780310K2 Li-Press-Pellets (HT-Hoch Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780320K2 Li-Press-Pellets (HT-Hoch Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780330K2 Li-Press-Pellets (HT-Hoch Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780340K2 Li-Press-Pellets (HT-Hoch Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781010K2 Li-Press-Pellets (LT-Low Transluzent) A1, 5X3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781020K2 Li-Press-Pellets (LT-Low Transluzent) A2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781030K2 Li-Press-Pellets (LT-Low Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781110K2 Li-Press-Pellets (LT-Low Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781120K2 Li-Press-Pellets (LT-Low Transluzent) B2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781210K2 Li-Press-Pellets (LT-Low Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781310K2 Li-Press-Pellets (LT-Low Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781320K2 Li-Press-Pellets (LT-Low Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781330K2 Li-Press-Pellets (LT-Low Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781340K2 Li-Press-Pellets (LT-Low Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38782010K2 Li-Press-Pellets (medium-opak) MO1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780010K2 Li Press-Pellets HT-A1Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780020K2 Li Press-Pellets HT-A2Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780030K2 Li-Press-Pellets (HT-Hoch Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38801100K2 MyStains Structure Body dark, SM-B-D, 2g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38760020K2 Li-Mamelon, MM-HO (HONEY), 20g.Yeti Dentalprodukte GmbHEIH2026-05-05
EYET38626150K2-HF OPAQUE DENTIN, OD-D3, 50g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38750060K2 Li-Clear, CL, 20g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38760010K2 Li-Mamelon, MM-OR (ORANGE), 20g.Yeti Dentalprodukte GmbHEIH2026-05-04