Jensen XT Zirconia 55027

GUDID 00817340024173

JENSEN INDUSTRIES INC.

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• Primary Device ID: 00817340024173
• NIH Device Record Key: 1f5ce716-7558-4db3-b312-85a24a12c3bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jensen XT Zirconia
• Version Model Number: Jensen XT TRAN Zr Mono C1 14mm Frame 2pk
• Catalog Number: 55027
• 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	00817340023664 [Primary]
GS1	00817340024173 [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: 2020-05-12
• Device Publish Date: 2020-05-04

On-Brand Devices [Jensen XT Zirconia]

• 00817340023305: Jensen XT Zr C3 98x18mm Disc
• 00817340023299: Jensen XT Zr B2 98x18mm Disc
• 00817340021745: Jensen XT Zr A3.5 98x18mm Disc
• 00817340021738: Jensen XT Zr OM3 98x14mm Disc
• 00817340021721: Jensen XT Zr OM2 98x14mm Disc
• 00817340021714: Jensen XT Zr OM1 98x14mm Disc
• 00817340021707: Jensen XT Zr D4 98x14mm Disc
• 00817340021691: Jensen XT Zr D3 98x14mm Disc
• 00817340021684: Jensen XT Zr C4 98x14mm Disc
• 00817340021677: Jensen XT Zr C3 98x14mm Disc
• 00817340021660: Jensen XT Zr C1 98x14mm Disc
• 00817340021653: Jensen XT Zr B4 98x14mm Disc
• 00817340021646: Jensen XT Zr B3 98x14mm Disc
• 00817340021639: Jensen XT Zr B2 98x14mm Disc
• 00817340021622: Jensen XT Zr A4 98x14mm Disc
• 00817340021615: Jensen XT Zr A3.5 98x14mm Disc
• 00817340021608: Jensen XT Zr Unshaded 98x18mm Disc
• 00817340021592: Jensen XT Zr Unshaded 98x14mm Disc
• 00817340021585: Jensen XT Zr Unshaded 98x12mm Disc
• 00817340021578: Jensen XT Zr Unshaded 98x10mm Disc
• 00817340021561: Jensen XT Zr Unshaded 15.4mm Frame 2pk
• 00817340021554: Jensen XT Zr Unshaded 14mm Frame 2pk
• 00817340021547: Jensen XT Zr Unshaded 24.5mm Frame 2pk
• 00817340021530: Jensen XT Zr Unshaded 12mm Frame 2pk
• 00817340021523: Jensen XT Zr D2 20mm Frames 2pk
• 00817340021516: Jensen XT Zr C2 20mm Frames 2pk
• 00817340021509: Jensen XT Zr B1 20mm Frames 2pk
• 00817340021493: Jensen XT Zr D2 98x18mm Disc
• 00817340021486: Jensen XT Zr C2 98x18mm Disc
• 00817340021479: Jensen XT Zr B1 98x18mm Disc
• 00817340021462: Jensen XT Zr D2 98x12mm Disc
• 00817340021455: Jensen XT Zr C2 98x12mm Disc
• 00817340021448: Jensen XT Zr B1 98x12mm Disc
• 00817340021431: Jensen XT Zr D2 12mm Frames 2pk
• 00817340021424: Jensen XT Zr B1 12mm Frames 2pk
• 00817340021417: Jensen XT Zr C2 12mm Frames 2pk
• 00817340021400: Jensen XT Zr A3 98x18mm Disc
• 00817340021394: Jensen XT Zr A2 98x18mm Disc
• 00817340021387: Jensen XT Zr A1 98x18mm Disc
• 00817340021370: Jensen XT Zr D2 98x14mm Disc
• 00817340021363: Jensen XT Zr C2 98x14mm Disc
• 00817340021356: Jensen XT Zr B1 98x14mm Disc
• 00817340021349: Jensen XT Zr A3 98x14mm Disc
• 00817340021332: Jensen XT Zr A2 98x14mm Disc
• 00817340021325: Jensen XT Zr A1 98x14mm Disc
• 00817340021318: Jensen XT Zr A3 98x12mm Disc
• 00817340021301: Jensen XT Zr A2 98x12mm Disc
• 00817340021295: Jensen XT Zr A1 98x12mm Disc
• 00817340021288: Jensen XT Zr Unshaded 20mm Frames 2pk
• 00817340021271: Jensen XT Zr A3 20mm Frames 2pk