NexxZr™ S / Z-95-12-NS-A400-SD
GUDID 00814356029369
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Dental appliance fabrication material, ceramic| Primary Device ID | 00814356029369 |
| NIH Device Record Key | 1df5263c-bf88-47cf-bdd4-6010787e1919 |
| Commercial Distribution Discontinuation | 2018-04-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | NexxZr™ S / Z-95-12-NS-A400-SD |
| Version Model Number | Z-42046 |
| Company DUNS | 002265727 |
| Company Name | SAGEMAX BIOCERAMICS, INC |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814356029369 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130991
FDA Product Code
| EIH | Powder, Porcelain |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2018-03-26 |
Devices Manufactured by SAGEMAX BIOCERAMICS, INC
Trademark Results [NexxZr]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXXZR 85234108 4136586 Live/Registered |
Sagemax Bioceramics, Inc. 2011-02-04 |
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