Primary Device ID | D800DSAD12530BPI0 |
NIH Device Record Key | 43f5140e-c6e9-4434-8c17-5c02d2b8d63e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Denture Giginva Basic Mono Blue Pink 125H30 |
Version Model Number | DSAD12530BPI |
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 Issuing Agency | Device ID |
---|---|
HIBCC | D800DSAD12530BPI0 [Primary] |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-14 |
Device Publish Date | 2025-04-04 |
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 |
D800DSCL9516B020 - Abro® Basic Multistratum® B2 95H16 | 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S |
D800DSCL9516B030 - Abro® Basic Multistratum® B3 95H16 | 2025-06-02 Content: 1 piece Height: 16mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. S |