Luminesse Zirconia Discs 19514-OFA

GUDID D79119514OFA0

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D79119514OFA0
• NIH Device Record Key: b3a7c326-d93c-4f6c-b5cc-708dab2c901d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Zirconia Discs
• Version Model Number: 19514-OFA
• Catalog Number: 19514-OFA
• 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	D79119514OFA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100232

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: 2018-12-21
• Device Publish Date: 2018-11-20

On-Brand Devices [Luminesse Zirconia Discs]

• D7916850C20: 6850-C2
• D7916850B30: 6850-B3
• D7916850B20: 6850-B2
• D7916850B10: 6850-B1
• D7916850A350: 6850-A3.5
• D7916850A30: 6850-A3
• D7916850A20: 6850-A2
• D7916850A10: 6850-A1
• D7916849C20: 6849-C2
• D7916849B30: 6849-B3
• D7916849B20: 6849-B2
• D7916849B10: 6849-B1
• D7916849A350: 6849-A3.5
• D7916849A30: 6849-A3
• D7916849A20: 6849-A2
• D7916849A10: 6849-A1
• D7915186HTT0: 5186HTT
• D7915186HT0: 5186HT
• D7915186HS0: 5186HS
• D7915185HTT0: 5185HTT
• D7915185HT0: 5185HT
• D7915185HS0: 5185HS
• D7915185AT0: 5185AT
• D7915183HTT0: 5183HTT
• D7915183HT0: 5183HT
• D7915183HS0: 5183HS
• D7915183AT0: 5183AT
• D7915182HTT0: 5182HTT
• D7915182HT0: 5182HT
• D7915182HS0: 5182HS
• D7915182AT0: 5182AT
• D7915181HTT0: 5181HTT
• D7915181HT0: 5181HT
• D7915181HS0: 5181HS
• D7915181AT0: 5181AT
• D7915180HTT0: 5180HTT
• D7915180HT0: 5180HT
• D7915180HS0: 5180HS
• D7915180AT0: 5180AT
• D7915179HTT0: 5179HTT
• D7915179HT0: 5179HT
• D7915179HS0: 5179HS
• D7915179AT0: 5179AT
• D7915178HTT0: 5178HTT
• D7915178HT0: 5178HT
• D7915178HS0: 5178HS
• D7915178AT0: 5178AT
• D79151760: 5176
• D7915175T0: 5175T
• D7915175ATV50: 5175ATV5