Ceramir® Protect LC Syringe 40044
GUDID 07350052430380
Doxa Dental AB
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | 07350052430380 |
| NIH Device Record Key | 3e9e70e7-3734-42e7-bcb6-9e115d3b3b06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ceramir® Protect LC Syringe |
| Version Model Number | 40044 |
| Catalog Number | 40044 |
| Company DUNS | 350486340 |
| Company Name | Doxa Dental AB |
| Device Count | 4 |
| 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 | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com | |
| Phone | 1.855.369-2872 |
| info@CeramirUS.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350052430380 [Unit of Use] |
| GS1 | 07350052430397 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202413
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 | 1 |
| Public Version Date | 2021-07-19 |
| Device Publish Date | 2021-07-11 |
On-Brand Devices [Ceramir® Protect LC Syringe]
| 07350052430403 | 40045 |
| 07350052430380 | 40044 |
Trademark Results [Ceramir]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERAMIR 79076446 3899347 Live/Registered |
Doxa AB 2009-11-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.