Luminesse Multilayer Anterior Zirconia AT 19814-OFAML-D3

GUDID D79119814OFAMLD30

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D79119814OFAMLD30
• NIH Device Record Key: 50209095-fc45-4802-9e57-f9479c471a95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Multilayer Anterior Zirconia AT
• Version Model Number: 19814-OFAML-D3
• Catalog Number: 19814-OFAML-D3
• Company DUNS: 094430642
• Company Name: TALLADIUM, 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79119814OFAMLD30 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152066

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-17

On-Brand Devices [Luminesse Multilayer Anterior Zirconia AT]

• D7915147MLATD30: 5147-MLAT-D3
• D7915147MLATD20: 5147-MLAT-D2
• D7915147MLATC30: 5147-MLAT-C3
• D7915147MLATC20: 5147-MLAT-C2
• D7915147MLATC10: 5147-MLAT-C1
• D7915147MLATB20: 5147-MLAT-B2
• D7915147MLATB10: 5147-MLAT-B1
• D7915147MLATA350: 5147-MLAT-A3.5
• D7915147MLATA30: 5147-MLAT-A3
• D7915144MLATD30: 5144-MLAT-D3
• D7915144MLATD20: 5144-MLAT-D2
• D7915144MLATC30: 5144-MLAT-C3
• D7915144MLATC20: 5144-MLAT-C2
• D7915144MLATC10: 5144-MLAT-C1
• D7915144MLATA10: 5144-MLAT-A1
• D79119820ATMLD20: 19820-ATML-D2
• D79119820ATMLC30: 19820-ATML-C3
• D79119820ATMLC20: 19820-ATML-C2
• D79119820ATMLC10: 19820-ATML-C1
• D79119820ATMLB30: 19820-ATML-B3
• D79119820ATMLB10: 19820-ATML-B1
• D79119820ATMLA350: 19820-ATML-A3.5
• D79119820ATMLA30: 19820-ATML-A3
• D79119820ATMLA20: 19820-ATML-A2
• D79119816ATMLA20: 19816-ATML-A2
• D79119814ATMLC20: 19814-ATML-C2
• D79119814ATMLB30: 19814-ATML-B3
• D79119814ATMLA10: 19814-ATML-A1