Vitapex
GUDID 04560128312530
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Endodontic filling/sealing material| Primary Device ID | 04560128312530 |
| NIH Device Record Key | 96881c23-59cc-4794-8f26-dc7bc5db9bba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vitapex |
| Version Model Number | Tips Set |
| 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 | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com | |
| Phone | 360-832-2458 |
| ndi@neodental-intl.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560128312530 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K973667
FDA Product Code
| KIF | Resin, Root Canal Filling |
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 | 2018-07-06 |
| Device Publish Date | 2016-12-08 |
On-Brand Devices [Vitapex]
| 04560128312554 | Intro Kit |
| 04560128312547 | Refill |
| 04560128312530 | Tips Set |
Trademark Results [Vitapex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITAPEX 86270892 4694772 Live/Registered |
Marketing Management LLC 2014-05-03 |
 VITAPEX 75448895 2245951 Live/Registered |
Neo Dental Chemical Products, Co., LTD 1998-03-12 |
 VITAPEX 75030580 not registered Dead/Abandoned |
Neo Dental Chemical Products Co., LTD 1995-10-20 |
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