ICE Plus 95H12

GUDID D800ZRAC80110

Content: 1 piece Height: 12 mm

ZIRKONZAHN SRL

Dental appliance fabrication material, ceramic

• Primary Device ID: D800ZRAC80110
• NIH Device Record Key: 9307001c-a47d-4bcc-8608-35adad5ca761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICE Plus 95H12
• Version Model Number: ZRAC8011
• Company DUNS: 564251911
• Company Name: ZIRKONZAHN SRL
• 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: 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
HIBCC	D800ZRAC80110 [Primary]

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: 2025-02-11
• Device Publish Date: 2025-02-03

Devices Manufactured by ZIRKONZAHN SRL

• D800ZRAC09010 - ICE Plus 98H10: 2025-02-11 Content: 1 piece Height: 10 mm
• D800ZRAC09110 - ICE Plus 98H14 with step: 2025-02-11 Content: 1 piece Height: 14 mm
• D800ZRAC09210 - ICE Plus 98H18 with step: 2025-02-11
• D800ZRAC09310 - ICE Plus 98H20 with step: 2025-02-11 ICE Plus 98H20 with step
• D800ZRAC09410 - ICE Plus 98H12 with step: 2025-02-11 Content: 1 piece Height: 12 mm
• D800ZRAC09510 - ICE Plus 98H22 with step: 2025-02-11 Content: 1 piece Height: 22 mm
• D800ZRAC09620 - ICE Plus 98H16 with step: 2025-02-11 Content: 1 piece Height: 16 mm
• D800ZRAC09710 - ICE Plus 98H25 with step: 2025-02-11 Content: 1 piece Height: 25 mm