| Primary Device ID | D807210641601 |
| NIH Device Record Key | e301d8fd-6221-42c4-835a-16cdf79a6e3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resolve® Ceramic |
| Version Model Number | 210-641-60 |
| Catalog Number | 210-641-60 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 10 |
| DM Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D807210641600 [Unit of Use] |
| HIBCC | D807210641601 [Primary] |
| NJM | Bracket, ceramic, orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-06-26 |
| D807K210152811 | Resolve® Ceramic M022 UL 5-5 CS BC HK |
| D807K210152121 | Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5 |
| D807K210152111 | Resolve® Ceramic R022 UL 5-5 CS BC HK |
| D807K210151811 | Resolve® Ceramic M018 UL 5-5 CS BC HK |
| D807K210151121 | Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5 |
| D807K210151111 | Resolve® Ceramic R018 UL 5-5 CS BC HK |
| D807210652611 | Resolve® Ceramic M022 L5 -17T0A0O HU |
| D807210652601 | Resolve® Ceramic M022 L5 -17T0A0O |
| D807210652101 | Resolve® Ceramic R022 L5 -22T0A0O HU |
| D807210651611 | Resolve® Ceramic M018 L5 -17T0A0O HU |
| D807210651601 | Resolve® Ceramic M018 L5 -17T0A0O |
| D807210651101 | Resolve® Ceramic R018 L5 -22T0A0O HU |
| D807210642611 | Resolve® Ceramic M022 L4 -12T0A0O HU |
| D807210642601 | Resolve® Ceramic M022 L4 -12T0A0O |
| D807210642101 | Resolve® Ceramic R022 L4 -17T0A0O HU |
| D807210641611 | Resolve® Ceramic M018 L4 -12T0A0O HU |
| D807210641601 | Resolve® Ceramic M018 L4 -12T0A0O |
| D807210641101 | Resolve® Ceramic R018 L4 -17T0A0O HU |
| D807210612601 | Resolve® Ceramic M022 L1-2 -6T0A0O |
| D807210612001 | Resolve® Ceramic R022 L1-2 0T0A0O |
| D807210611601 | Resolve® Ceramic M018 L1-2 -6T0A0O |
| D807210611001 | Resolve® Ceramic R018 L1-2 0T0A0O |
| D807210552611 | Resolve® Ceramic M022 U5 -7T0A0O HU |
| D807210552601 | Resolve® Ceramic M022 U5 -7T0A0O |
| D807210551611 | Resolve® Ceramic M018 U5 -7T0A0O HU |
| D807210551601 | Resolve® Ceramic M018 U5 -7T0A0O |
| D807210542611 | Resolve® Ceramic M022 U4 -7T0A0O HU |
| D807210542601 | Resolve® Ceramic M022 U4 -7T0A0O |
| D807210542101 | Resolve® Ceramic R022 U4-5 -7T0A0O HU |
| D807210541611 | Resolve® Ceramic M018 U4 -7T0A0O HU |
| D807210541601 | Resolve® Ceramic M018 U4 -7T0A0O |
| D807210541101 | Resolve® Ceramic R018 U4-5 -7T0A0O HU |
| D807210432611 | Resolve® Ceramic M022 LL3 -6T3A0O HD |
| D807210432101 | Resolve® Ceramic R022 LL3 -11T5A2O HD |
| D807210431611 | Resolve® Ceramic M018 LL3 -6T3A0O HD |
| D807210431101 | Resolve® Ceramic R018 LL3 -11T5A2O HD |
| D807210332611 | Resolve® Ceramic M022 LR3 -6T3A0O HD |
| D807210332101 | Resolve® Ceramic R022 LR3 -11T5A2O HD |
| D807210331611 | Resolve® Ceramic M018 LR3 -6T3A0O HD |
| D807210331101 | Resolve® Ceramic R018 LR3 -11T5A2O HD |
| D807210232611 | Resolve® Ceramic M022 UL3 -7T8A0O HD |
| D807210232101 | Resolve® Ceramic R022 UL3 0T11A4O HD |
| D807210231611 | Resolve® Ceramic M018 UL3 -7T8A0O HD |
| D807210231101 | Resolve® Ceramic R018 UL3 0T11A4O HD |
| D807210222601 | Resolve® Ceramic M022 UL2 10T8A0O |
| D807210222001 | Resolve® Ceramic R022 UL2 8T9A0O |
| D807210221601 | Resolve® Ceramic M018 UL2 10T8A0O |
| D807210221001 | Resolve® Ceramic R018 UL2 8T9A0O |
| D807210212601 | Resolve® Ceramic M022 UL1 17T4A0O |
| D807210212001 | Resolve® Ceramic R022 UL1 12T5A0O |