Imagine Zirconia 56070

GUDID 00817340023930

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: 00817340023930
• NIH Device Record Key: 76e413fa-cad3-4ce5-ae34-66021dc65c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imagine Zirconia
• Version Model Number: Imagine X TRAN Zr A3 14mm Frame 2pk
• Catalog Number: 56070
• Company DUNS: 060018587
• Company Name: JENSEN INDUSTRIES INC.
• Device Count: 2
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817340023428 [Primary]
GS1	00817340023930 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112806

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: 2021-11-16
• Device Publish Date: 2021-11-08

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