Imagine Zirconia MI012

GUDID 00817340025101

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: 00817340025101
• NIH Device Record Key: 29a14f14-50e8-42d3-8d04-43cd1cd5b440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imagine Zirconia
• Version Model Number: Imagine Enamel Liquid 15ml
• Catalog Number: MI012
• Company DUNS: 060018587
• Company Name: JENSEN 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817340025101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183408

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [Imagine Zirconia]

• 00817340023206: Imagine Zr Multilayered B3 98x14mm Disc
• 00817340023190: Imagine Zr Multilayered B2 98x14mm Disc
• 00817340023183: Imagine Zr Multilayered B1 98x14mm Disc
• 00817340023176: Imagine Zr Multilayered A3.5 98x14mm Disc
• 00817340023169: Imagine Zr Multilayered A4 98x14mm Disc
• 00817340023152: Imagine Zr Multilayered A3 98x14mm Disc
• 00817340023145: Imagine Zr Multilayered A2 98x14mm Disc
• 00817340023138: Imagine Zr Multilayered A1 98x14mm Disc
• 00817340022285: Imagine Micro Layering Kit
• 00817340022278: Imagine Zr Unshaded 98x22mm Disc
• 00817340022261: Imagine Zr Unshaded 98x12mm Disc
• 00817340022254: Imagine Zr Unshaded 18mm Frame 2pk
• 00817340022247: Imagine Zr Unshaded 14mm Frame 2pk
• 00817340022230: Imagine Zr Unshaded 98x18mm Disc
• 00817340022223: Imagine Zr Unshaded 98x14mm Disc
• 00817340025637: Imagine Zr Multilayered BL 98x14mm Disc
• 00817340025620: Imagine Zr Multilayered D4 98x14mm Disc
• 00817340025613: Imagine Zr Multilayered D3 98x14mm Disc
• 00817340025606: Imagine Zr Multilayered D2 98x14mm Disc
• 00817340025590: Imagine Zr Multilayered C4 98x14mm Disc
• 00817340025583: Imagine Zr Multilayered C3 98x14mm Disc
• 00817340025576: Imagine Zr Multilayered C2 98x14mm Disc
• 00817340025569: Imagine Zr Multilayered C1 98x14mm Disc
• 00817340025552: Imagine Zr Multilayered B4 98x14mm Disc
• 00817340023282: Imagine Zr Multilayered B3 98x18mm Disc
• 00817340023275: Imagine Zr Multilayered B2 98x18mm Disc
• 00817340023268: Imagine Zr Multilayered B1 98x18mm Disc
• 00817340023251: Imagine Zr Multilayered A3.5 98x18mm Disc
• 00817340023244: Imagine Zr Multilayered A4 98x18mm Disc
• 00817340023237: Imagine Zr Multilayered A3 98x18mm Disc
• 00817340023220: Imagine Zr Multilayered A2 98x18mm Disc
• 00817340023213: Imagine Zr Multilayered A1 98x18mm Disc
• 00817340025101: Imagine Enamel Liquid 15ml
• 00817340025095: Imagine X TRAN Zr A1 98x22 Disc
• 00817340024579: Imagine X TRAN Zr D4 98x14 Disc
• 00817340024555: Imagine X TRAN Zr D2 98x14 Disc
• 00817340024548: Imagine X TRAN Zr C4 98x14 Disc
• 00817340024531: Imagine X TRAN Zr C3 98x14 Disc
• 00817340024524: Imagine X TRAN Zr C2 98x14 Disc
• 00817340024517: Imagine X TRAN Zr C1 98x14 Disc
• 00817340024500: Imagine X TRAN Zr B4 98x14 Disc
• 00817340024494: Imagine X TRAN Zr B3 98x14 Disc
• 00817340024487: Imagine X TRAN Zr B2 98x14 Disc
• 00817340024470: Imagine X TRAN Zr B1 98x14 Disc
• 00817340024463: Imagine X TRAN Zr A4 98x14 Disc
• 00817340024456: Imagine X TRAN Zr A3.5 98x14 Disc
• 00817340024449: Imagine X TRAN Zr A3 98x14 Disc
• 00817340024432: Imagine X TRAN Zr A2 98x14 Disc
• 00817340024425: Imagine X TRAN Zr A1 98x14 Disc
• 00817340025767: Imagine Enamel Liquid 2 15ml