Cavios
GUDID 04560128312561
Cavity Liner
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Dental composite resin| Primary Device ID | 04560128312561 |
| NIH Device Record Key | a6fb04cd-aae3-4f73-b84b-5cae8de68817 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cavios |
| Version Model Number | ― |
| Company DUNS | 691229181 |
| Company Name | NEO DENTAL CHEMICAL PRODUCTS CO.,LTD. |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | 253-946-0814 |
| karin@neodental-intl.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560128312561 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111668
FDA Product Code
| EJK | Liner, Cavity, Calcium Hydroxide |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-16 |
Devices Manufactured by NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
| 14560128312629 - Neo Blue Tips | 2021-05-21 |
| 04560128312530 - Vitapex | 2018-07-06 |
| 04560128312547 - Vitapex | 2018-07-06 |
| 04560128312554 - Vitapex | 2018-07-06 |
| 04560128312561 - Cavios | 2018-07-06Cavity Liner |
| 04560128312561 - Cavios | 2018-07-06 Cavity Liner |
| 04560128312578 - EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | 2018-07-06 Temporary Crown and Bridge Resin |
| 04560128312585 - Dentalis | 2018-07-06 Endodontic sealing material, 15g Powder, 10mL Liquid |
| 04560128312592 - Dentalis | 2018-07-06 Endodontic sealing material, 15g Powder |
Trademark Results [Cavios]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAVIOS 77696467 4132218 Live/Registered |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 2009-03-22 |
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