Luminesse Zirconia Blocks

GUDID D7915162B10

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7915162B10
• NIH Device Record Key: 8221e104-2011-4332-b15c-369611ccbe04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Zirconia Blocks
• Version Model Number: 5162B1
• 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: false
• 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	D7915162B10 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-10-24

On-Brand Devices [Luminesse Zirconia Blocks]

• D7915276HT0: 5276HT
• D7915276HS0: 5276HS
• D7915250HT0: 5250HT
• D79151690: 5169
• D79151680: 5168
• D79151670: 5167
• D79151650: 5165
• D79151630: 5163
• D7915162D20: 5162D2
• D7915162C20: 5162C2
• D7915162C10: 5162C1
• D7915162B20: 5162B2
• D7915162B10: 5162B1
• D7915162A30: 5162A3
• D7915162A20: 5162A2
• D7915162A10: 5162A1
• D79151620: 5162
• D7915161HS0: 5161HS
• D7915160HS0: 5160HS
• D79151590: 5159
• D79151570: 5157
• D79151560: 5156
• D79151550: 5155
• D79151480: 5148
• D79151470: 5147
• D79151460: 5146
• D79151450: 5145
• D79151440: 5144
• D79151430: 5143
• D79151420: 5142
• D79151410: 5141
• D79151400: 5140
• D79151390: 5139
• D7915138D20: 5138D2
• D7915138C20: 5138C2
• D7915138C10: 5138C1
• D7915138B20: 5138B2
• D7915138B10: 5138B1
• D7915138A30: 5138A3
• D7915138A20: 5138A2
• D79151380: 5138
• D79151370: 5137
• D79151360: 5136
• D79151350: 5135
• D79151340: 5134
• D7915133D20: 5133D2