Ceramir® Restore QuikCap 40039
GUDID 07350052430311
Doxa Dental AB
Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement 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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