R2iCE
GUDID 08800118617440
U&C International Co.,Ltd
Dental appliance fabrication material, ceramic| Primary Device ID | 08800118617440 |
| NIH Device Record Key | e07915e5-de09-4ea8-a4ab-2b315be02ed1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R2iCE |
| Version Model Number | R2iCE Zirconia Block PT C2 98 * 28T |
| 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 | 08800118617440 [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 | 2022-03-09 |
| Device Publish Date | 2022-03-01 |
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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