| Primary Device ID | 00840018603165 |
| NIH Device Record Key | e09490a0-36e8-489a-9940-2b03a0ad4606 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BURKHART DENTAL |
| Version Model Number | E44/BH |
| 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 | 00840018603165 [Primary] |
| EMJ | Elevator, Surgical, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00840018603165]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2020-05-20 |
| 00840018603103 | BDS DRESS.PLIERS DP3E ENDO ECONOMY |
| 00840018603097 | BDS DRESS.PLIERS DP3 ENDO LOCK PREM |
| 00840018603080 | BDS DRESS.PLIERS DP2E LOCK ECONOMY |
| 00840018603073 | BDS DRESS.PLIERS DP2 LOCKING PREM |
| 00840018603066 | BDS DRESS.PLIERS DP1E STD ECONOMY |
| 00840018603059 | BDS DRESS.PLIERS DP1 PREMIUM |
| 00840018603721 | BURKHART CORD PACKER #N122 SER TP |
| 00840018603714 | BURKHART CORD PACKER #N122 PLN TP |
| 00840018603707 | BURKHART CORD PACKER #N113 SER TP (OFFSE |
| 00840018603691 | BURKHART CORD PACKER #N113 PLAN TP (OFFS |
| 00840018603004 | BURKHART CALCIUM HYDROXIDE PLACEMENT CHP |
| 00840018602991 | BDS CARVER DE WILAND #18 INTERPROXIMAL |
| 00840018602984 | BDS CARVER DE SHO-A |
| 00840018602977 | BDS CARVER INTERPROXIMAL OFF ANGLE |
| 00840018602960 | BDS CARVER DE IPC INTERPROXIMAL |
| 00840018602953 | BDS CARVER DE HOLLENBACK #3S (SMALL) |
| 00840018602946 | BDS CARVER DE HOLLENBACK #3 |
| 00840018602939 | BDS CARVER, DE HOLLENBACK #1/2 |
| 00840018602922 | BDS CLEOID-DISCOID #3 (LARGE) |
| 00840018602915 | BDS CLEOID-DISCOID #89/92 (MEDIUM) |
| 00840018602908 | BDS CLEOID-DISCOID #1 |
| 00840018657496 | BURKHART EXTRACTION FORCEPS 1-2 UPPER MOLAR ANAT #88 |
| 00840018603301 | BDS ELEV#3 HEIDBRINK PREM |
| 00840018603295 | BDS ELEV#2 HEIDBRINK PREM |
| 00840018603288 | BURKHART RT PK D EHEIDBRINK #2-3 STD HDL |
| 00840018603271 | BDS ELEV #1 HEIDBRINK PREM |
| 00840018603264 | BDS PERIOSTEAL SELDIN #23 |
| 00840018603257 | BURKHART PERIOST ELEVATOR DE #3 STD HDL |
| 00840018603240 | BURKHART PERIOSTEAL ALLEN #9A |
| 00840018603233 | BDS PERIOSTEAL, MOLT #9 |
| 00840018603202 | BURKHART BEIN LUXATING ELEVATOR 2MM STRA |
| 00840018603196 | BURKHART BEIN LUXATING ELEVATOR 2MM CURV |
| 00840018603158 | BURKHART BEIN LUXATING ELEVATOR 3.0MM ST |
| 00840018603141 | BURKHART BEIN LUXATING ELEVATOR 3MM CURV |
| 00840018603851 | BDS NH #212 HEGR-BAUM 5 1/4" PREM |
| 00840018603844 | BDS NH #209 CASTRO LOCK 5 3/4" PREM |
| 00840018603837 | BDS NH #204 CRILE-WOOD 6" PREM |
| 00840018603820 | BDS NH #202 MAYO-HEGAR 6" PREM |
| 00840018660915 | BDS EXPRO DE #23/CO-11 PROBE CC STANDARD |
| 00840018604209 | BDS RT CANL SPRD SE #D11T-NITI STD HN |
| 00840018603219 | BURKHART ELEVATOR #77R 201 HDL |
| 00840018603189 | BDS ELEV #46 CRYER PREMIUM |
| 00840018603172 | BDS ELEV #45 CRYER MED.RT PREM |
| 00840018603165 | BDS ELEV #44 CRYER MED.LEFT PREM |
| 00840018603134 | BDS ELEV #34S SELDIN PREMIUM |
| 00840018603127 | BDS ELEV #34 SELDIN PREMIUM |
| 00840018603110 | BDS ELEV #301 APICAL PREMIUM |