| Primary Device ID | 00840018638945 |
| NIH Device Record Key | 53ade307-8265-46fa-a90a-f72e8650051e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NORDENT MANUFACTURING INC |
| Version Model Number | REOTN114 |
| Company DUNS | 053187985 |
| Company Name | NORDENT MANUFACTURING INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840018638945 [Primary] |
| ECR | Setter, Band, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018638945]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-17 |
| Device Publish Date | 2020-06-09 |
| 00840018634992 | COMPOSITE PLACEMENT INST. #7 |
| 00840018634985 | COM PLACM INST CP2 #6 STD HDL |
| 00840018634978 | COM PLACM INST DE #5 STD HDL |
| 00840018634961 | COM PLACEMENT INST DE - HOE |
| 00840018634954 | COMPOSITE INSTRUMENT BALDWIN # |
| 00840018634947 | COMPOSITE INST W3A-SHEV. STD H |
| 00840018634930 | COM PLACM INST DE #4 STD HDL |
| 00840018634923 | COMPOSITE PLACEMENT INST. 3 RO |
| 00840018634916 | COMPOSITE INSTRUMENT PFI#39, S |
| 00840018634909 | PLASTIC FILLER #3 OZDENT |
| 00840018634893 | COM PLACM INST DE #3 STD HDL |
| 00840018634886 | COMPOSITE INST PFI26, UNCOATED |
| 00840018634879 | COMPOSITE PLACEM INST #23 STD |
| 00840018634862 | COM PLACM INST DE #20 STD HNDL |
| 00840018634855 | COM PLACM INST DE #2 STD HDL |
| 00840018634848 | COMP. INST PFI1 - THIN BLADES |
| 00840018634831 | COMPOSITE INST PFI1A-3B |
| 00840018634824 | COMPOSITE PLACEMENT INST. #179 |
| 00840018634817 | PFI STANDARD HANDLE |
| 00840018634800 | COMPOSITE INST PFI11 |
| 00840018634794 | COM PLACM INST DE #1 STD HDL |
| 00840018634787 | SE SCRAPER 1A |
| 00840018634770 | COMPOSITE INST ATLAGIC 1A STAI |
| 00840018634763 | ANODIZED COMPOSITE INST #F5 |
| 00840018634756 | ANODIZED COMPOSITE INST. #F1 |
| 00840018634749 | ANODIZED COMPOSITE INST. #F6 |
| 00840018634732 | ANODIZED COMPOSITE INST. #F3 |
| 00840018634725 | ANODIZED COMPOSITE INST #F2 |
| 00840018634718 | ANODIZED COMPOSITE INST. #F4 |
| 00840018634701 | PLASTIC FILLING |
| 00840018634350 | CAVITY PREP INST, T8-9, DL-CC |
| 00840018634343 | MARGIN TRIMMER, DE, #79-80, CO |
| 00840018634336 | MARGIN TRIMMER #77-78 (15-95-8 |
| 00840018634329 | WEDELSTADT CHISEL,DE,#5-6 COLO |
| 00840018634312 | HOE, DE, #40-41 (18-10-16)COLO |
| 00840018634305 | WEDELSTADT CHISEL, DE, #3-4 CO |
| 00840018634299 | MARG TRIM DE (10-80-7-14) COLO |
| 00840018634282 | MARGIN TRIMMER, DE, #28(10-95- |
| 00840018604827 | MIRROR HEAD, #4 DOUBLE SIDED, |
| 00840018648326 | COMPOSITE INSTRUMENT PFI11A-3B |
| 00840018648296 | COMPOSITE PLACEMENT INSTRUMENT, 2BT-3AT |
| 00840018648272 | COMPOSITE INST. #20BT-30BT TIN |
| 00840018648036 | COMPOSITE INST TIN 39A-30A CC |
| 00840018647664 | TIN COMP.INST.RND CONDENSER/PADDLE |
| 00840018647329 | COMPOSITE PLACEMENT STANDARD HNDL |
| 00840018647282 | COMPOSIT PLACEMENT, 2TB-54TA |
| 00840018647244 | COM PLACEM INST DE, #40-30 TIN, DL HNDL |
| 00840018647107 | COMPOSITE INST GROVE DENTAL SPECIAL |
| 00840018647015 | COM PLACM INST DE #7 DL-R |
| 00840018646902 | COM PLACM INST DE #4T DILLYT DL-R |