ICE Plus 98H16 with step

GUDID D800ZRAC09620

Content: 1 piece Height: 16 mm

ZIRKONZAHN SRL

Dental appliance fabrication material, ceramic

• Primary Device ID: D800ZRAC09620
• NIH Device Record Key: 3452157e-53eb-4ad0-a8d6-62e8c6342102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICE Plus 98H16 with step
• Version Model Number: ZRAC0962
• 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	D800ZRAC09620 [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

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• D800SY16700 - ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation: 2025-09-15 Zirkonzahn.Implant-Planner Practice incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Pl
• D800DSCL9516A010 - Abro® Basic Multistratum® A1 95H16: 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S
• D800DSCL9516A020 - Abro® Basic Multistratum® A2 95H16: 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S
• D800DSCL9516A030 - Abro® Basic Multistratum® A3 95H16: 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S
• D800DSCL9516A040 - Abro® Basic Multistratum® A4 95H16: 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S
• D800DSCL9516A350 - Abro® Basic Multistratum® A3,5 95H16: 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S
• D800DSCL9516B010 - Abro® Basic Multistratum® B1 95H16: 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S