NexxZr™ T / D-98-18-NT-WT00-SD
GUDID 00842271109842
SAGEMAX BIOCERAMICS, INC
Dental appliance fabrication material, ceramic| Primary Device ID | 00842271109842 |
| NIH Device Record Key | c9f65aa2-e9d5-4d54-8bab-c10afd7ba50d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NexxZr™ T / D-98-18-NT-WT00-SD |
| Version Model Number | D-31005 |
| 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842271109842 [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 | 3 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2018-01-24 |
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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