Luxisse+ MDD3937ZS14S3

GUDID 00817724021255

YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE

HEANY INDUSTRIES, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: 00817724021255
• NIH Device Record Key: ddddde1b-5261-480d-be98-56769a547b1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luxisse+
• Version Model Number: 0
• Catalog Number: MDD3937ZS14S3
• Company DUNS: 002221091
• Company Name: HEANY INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5858892700
• Email: cliffr@heany.com
• Phone: 5858892700
• Email: cliffr@heany.com

Device Dimensions

• Outer Diameter: 100 Millimeter
• Outer Diameter: 100 Millimeter
• Outer Diameter: 100 Millimeter
• Outer Diameter: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817724021255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150056

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2017-02-24

On-Brand Devices [Luxisse+]

• 00817724022078: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021859: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021842: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021835: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021828: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021811: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021804: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021798: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021781: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021774: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021767: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021750: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021743: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021736: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021729: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021712: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021705: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021699: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021521: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021514: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021507: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021460: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021453: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021446: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021439: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021422: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021415: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021408: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021392: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021385: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021378: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021361: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021354: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021347: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021330: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021323: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021316: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021309: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021293: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021286: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021279: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021262: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021255: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021248: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021231: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021224: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021217: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021200: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021194: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE
• 00817724021187: YTTRIA STABILIZED ZIRCONIA, 600 MPa BEND STRENGTH, 49% LIGHT TRANSMITTANCE