Ceramir® Restore QuikCap 40039
GUDID 07350052430311
Doxa Dental AB
Glass ionomer dental cement| Primary Device ID | 07350052430311 |
| NIH Device Record Key | ad1ae1d5-3ba7-4dc7-9279-fab53eb79479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ceramir® Restore QuikCap |
| Version Model Number | 40039 |
| Catalog Number | 40039 |
| Company DUNS | 350486340 |
| Company Name | Doxa Dental AB |
| Device Count | 5 |
| 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 | 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 | |
| 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 | 07350052430311 [Unit of Use] |
| GS1 | 07350052430328 [Primary] |
| GS1 | 07350052430335 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201937
FDA Product Code
| EMA | Cement, Dental |
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 | 2021-01-08 |
| Device Publish Date | 2020-12-31 |
Devices Manufactured by Doxa Dental AB
| 07350052430182 - Ceramir Applicator 2 | 2023-06-16 |
| 07350052430380 - Ceramir® Protect LC Syringe | 2021-07-19 |
| 07350052430403 - Ceramir® Protect LC Syringe | 2021-07-19 |
| 07350052430311 - Ceramir® Restore QuikCap | 2021-01-08 |
| 07350052430311 - Ceramir® Restore QuikCap | 2021-01-08 |
| 07350052430298 - Ceramir Bioceramic Implant Cement QuikCap | 2019-03-28 |
| 07350052430151 - Ceramir Crown & Bridge QuikCap | 2018-09-17 |
| 07350052430168 - Ceramir Crown & Bridge QuikCap | 2018-09-17 |
| 07350052430175 - Ceramir Crown & Bridge QuikCap | 2018-09-17 |
Trademark Results [Ceramir]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERAMIR 79076446 3899347 Live/Registered |
Doxa AB 2009-11-13 |
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