Primary Device ID | D807210651101 |
NIH Device Record Key | 2a7006e8-0e05-4423-b890-837b0da29f46 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Resolve® Ceramic |
Version Model Number | 210-651-10 |
Catalog Number | 210-651-10 |
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 | D807210651100 [Unit of Use] |
HIBCC | D807210651101 [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 |