R2iCE
GUDID 08800118607670
U&C International Co.,Ltd
Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic| Primary Device ID | 08800118607670 |
| NIH Device Record Key | 4244e4f8-1458-4625-9ed1-b14cdf670247 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R2iCE |
| Version Model Number | R2iCE Zirconia Block AT A3.5 98 * 20T |
| Company DUNS | 694821663 |
| Company Name | U&C International 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800118607670 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191902
FDA Product Code
| EIH | Powder, Porcelain |
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 | 2022-02-21 |
| Device Publish Date | 2022-02-12 |
On-Brand Devices [R2iCE]
| 08800118608257 | R2iCE Zirconia Block PT A4 98 * 30T |
| 08800118608240 | R2iCE Zirconia Block PT A4 98 * 28T |
| 08800118608233 | R2iCE Zirconia Block PT A4 98 * 25T |
| 08800118608226 | R2iCE Zirconia Block PT A4 98 * 22T |
| 08800118608219 | R2iCE Zirconia Block PT A4 98 * 20T |
| 08800118608202 | R2iCE Zirconia Block PT A4 98 * 18T |
| 08800118608196 | R2iCE Zirconia Block PT A4 98 * 16T |
| 08800118608189 | R2iCE Zirconia Block PT A4 98 * 14T |
| 08800118608172 | R2iCE Zirconia Block PT A4 98 * 12T |
| 08800118608165 | R2iCE Zirconia Block PT A3.5 98 * 30T |
| 08800118608158 | R2iCE Zirconia Block PT A3.5 98 * 28T |
| 08800118608141 | R2iCE Zirconia Block PT A3.5 98 * 25T |
| 08800118608134 | R2iCE Zirconia Block PT A3.5 98 * 22T |
| 08800118608127 | R2iCE Zirconia Block PT A3.5 98 * 20T |
| 08800118608110 | R2iCE Zirconia Block PT A3.5 98 * 18T |
| 08800118608103 | R2iCE Zirconia Block PT A3.5 98 * 16T |
| 08800118608097 | R2iCE Zirconia Block PT A3.5 98 * 14T |
| 08800118608080 | R2iCE Zirconia Block PT A3.5 98 * 12T |
| 08800118608073 | R2iCE Zirconia Block PT A3 98 * 30T |
| 08800118608066 | R2iCE Zirconia Block PT A3 98 * 28T |
| 08800118608059 | R2iCE Zirconia Block PT A3 98 * 25T |
| 08800118608042 | R2iCE Zirconia Block PT A3 98 * 22T |
| 08800118608035 | R2iCE Zirconia Block PT A3 98 * 20T |
| 08800118608028 | R2iCE Zirconia Block PT A3 98 * 18T |
| 08800118608011 | R2iCE Zirconia Block PT A3 98 * 16T |
| 08800118608004 | R2iCE Zirconia Block PT A3 98 * 14T |
| 08800118607991 | R2iCE Zirconia Block PT A3 98 * 12T |
| 08800118607984 | R2iCE Zirconia Block PT A2 98 * 30T |
| 08800118607977 | R2iCE Zirconia Block PT A2 98 * 28T |
| 08800118607960 | R2iCE Zirconia Block PT A2 98 * 25T |
| 08800118607953 | R2iCE Zirconia Block PT A2 98 * 22T |
| 08800118607946 | R2iCE Zirconia Block PT A2 98 * 20T |
| 08800118607939 | R2iCE Zirconia Block PT A2 98 * 18T |
| 08800118607922 | R2iCE Zirconia Block PT A2 98 * 16T |
| 08800118607915 | R2iCE Zirconia Block PT A2 98 * 14T |
| 08800118607908 | R2iCE Zirconia Block PT A2 98 * 12T |
| 08800118607892 | R2iCE Zirconia Block PT A1 98 * 30T |
| 08800118607885 | R2iCE Zirconia Block PT A1 98 * 28T |
| 08800118607878 | R2iCE Zirconia Block PT A1 98 * 25T |
| 08800118607861 | R2iCE Zirconia Block PT A1 98 * 22T |
| 08800118607854 | R2iCE Zirconia Block PT A1 98 * 20T |
| 08800118607847 | R2iCE Zirconia Block PT A1 98 * 18T |
| 08800118607830 | R2iCE Zirconia Block PT A1 98 * 16T |
| 08800118607823 | R2iCE Zirconia Block PT A1 98 * 14T |
| 08800118607816 | R2iCE Zirconia Block PT A1 98 * 12T |
| 08800118607809 | R2iCE Zirconia Block AT A4 98 * 30T |
| 08800118607793 | R2iCE Zirconia Block AT A4 98 * 28T |
| 08800118607786 | R2iCE Zirconia Block AT A4 98 * 25T |
| 08800118607779 | R2iCE Zirconia Block AT A4 98 * 22T |
| 08800118607762 | R2iCE Zirconia Block AT A4 98 * 20T |
Trademark Results [R2iCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 R2ICE 79311356 not registered Live/Pending |
MEGAGEN IMPLANT CO., LTD. 2021-03-12 |
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