Denture Giginva Basic Mono Cherry Pink 125H16

GUDID D800DSAD12516CPI0

Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and fracture resistance. Specifically designed for the production of denture bases.

ZIRKONZAHN SRL

Dental bridge, polymer

• Primary Device ID: D800DSAD12516CPI0
• NIH Device Record Key: 4ee1e828-823f-43ca-8e2e-9cd740b874cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Denture Giginva Basic Mono Cherry Pink 125H16
• Version Model Number: DSAD12516CPI
• 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: 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
HIBCC	D800DSAD12516CPI0 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2025-04-14
• Device Publish Date: 2025-04-04

Devices Manufactured by ZIRKONZAHN SRL

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• 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