| Primary Device ID | D800SY16700 |
| NIH Device Record Key | d2bdd840-4e8d-4146-abb7-3bda0fab0477 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation |
| Version Model Number | SY1670 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | D800SY16700 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
| D800SY16600 - ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation | 2025-09-15 Zirkonzahn.Implant-Planner incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Planner ser |
| D800SY16700 - ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation | 2025-09-15Zirkonzahn.Implant-Planner Practice incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months! |
| 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 |