Zolid Bion 768346
GUDID E4947683461
Amann Girrbach AG
Dental appliance fabrication material, ceramic| Primary Device ID | E4947683461 |
| NIH Device Record Key | 118167a6-c9de-47c5-8331-39dd8af4be5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zolid Bion |
| Version Model Number | Zolid Bion C2 98x30 F |
| Catalog Number | 768346 |
| Company DUNS | 300708950 |
| Company Name | Amann Girrbach AG |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | E4947683461 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171876
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 | 2024-11-25 |
| Device Publish Date | 2024-11-15 |
On-Brand Devices [Zolid Bion]
| E4947683701 | Zolid Bion D2 98x30 F |
| E4947683461 | Zolid Bion C2 98x30 F |
| E4947683141 | Zolid Bion B2 98x30 F |
| E4947683061 | Zolid Bion B1 98x30 F |
| E4947682901 | Zolid Bion A3,5 98x30 F |
| E4947682821 | Zolid Bion A3 98x30 F |
| E4947682741 | Zolid Bion A2 98x30 F |
| E4947682661 | Zolid Bion A1 98x30 F |
| E4947682561 | Zolid Bion BL4 98x20 F |
| E4947682541 | Zolid Bion BL4 98x16 F |
| E4947682531 | Zolid Bion BL4 98x14 F |
| E4947682501 | Zolid Bion BL3 98x30 F |
| E4947682491 | Zolid Bion BL3 98x25 F |
| E4947682471 | Zolid Bion BL3 98x18 F |
| E4947682441 | Zolid Bion BL3 98x12 F |
| E4947682341 | Zolid Bion BL1 98x30 F |
| E4947682261 | Zolid Bion BL0 98x30 F |
| E4947682251 | Zolid Bion BL0 98x25 F |
| E4947682241 | Zolid Bion BL0 98x20 F |
| E4947682231 | Zolid Bion BL0 98x18 F |
| E4947682221 | Zolid Bion BL0 98x16 F |
| E4947682211 | Zolid Bion BL0 98x14 F |
| E4947682201 | Zolid Bion BL0 98x12 F |
Trademark Results [Zolid Bion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZOLID BION 79379075 not registered Live/Pending |
Amann Girrbach AG 2023-08-03 |
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