Nordent Manufacturing Inc
Burnisher, DE, Titanium-Nitride Coated, Small Dilly Tapered Cone and Small Acorn Duralite ROUND Handle
5manufacturers in China registered for this device type
157catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Nordent Manufacturing Inc |
|---|---|
| FDA product code | EKJ |
| Device type | Burnisher, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-05-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment humidity 40 to 60 % RH; Handling environment temperature 0 to 350 °F; Storage environment temperature 65 to 75 °F |
| Sizes | Length 6.5 to 7 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR21BB-4 | In distribution | |
| CEBR21BA | In distribution | |
| BR45T/BG6 | Length 6.5 in | In distribution |
| EBR28-29 | In distribution | |
| RECN4P8T | In distribution | |
| BRDILLYA-21BA | In distribution | |
| RECAIPCT | In distribution | |
| REBRDYTB-20TB | In distribution | |
| CEBR29-BV | In distribution | |
| CEBR21B | In distribution | |
| REBRDILLY-21AT | Length 6.5 in | In distribution |
| BRN117ST | In distribution | |
| BR3-BV | In distribution | |
| BUR1-2 | In distribution | |
| REBR29-21B | In distribution | |
| REBR26-29T | In distribution | |
| CECAIPCT | In distribution | |
| REBRN117 | In distribution | |
| REBR26-27S | In distribution | |
| REBRLAD-3 | In distribution | |
| EBR42 | In distribution | |
| BRBUR2 | In distribution | |
| RECN0P1T | In distribution | |
| EBR29-BV | In distribution | |
| RBRN117S | In distribution | |
| RECN1-P-4T | In distribution | |
| REBRN117A-PFI5B | In distribution | |
| RECN4-P-8T | In distribution | |
| RECALL1T | In distribution | |
| REBR45T | In distribution | |
| REBRDYAT-20BT | In distribution | |
| BSH0512 | In distribution | |
| RBR21B | In distribution | |
| BUR2892 | Length 7.0 in | In distribution |
| CEBRDILLYT | In distribution | |
| BR2-CHP1 | In distribution | |
| EBR21B | In distribution | |
| REBR45 | In distribution | |
| REBR21BT | In distribution | |
| RCB1-P-4T | In distribution | |
| BR45 | In distribution | |
| CEBR27-27S | In distribution | |
| EBR28-29 | In distribution | |
| EBR27S-29 | In distribution | |
| REBR28-29 | In distribution | |
| CEBR26-29 | In distribution | |
| CEBRN117 | In distribution | |
| REBR25-29 | In distribution | |
| REBR27T-29 | In distribution | |
| BRDILLYB-BR29 | In distribution | |
| CEBR21BT | In distribution | |
| CEBR27S-29 | Length 6.5 in | In distribution |
| CEBR45T | In distribution | |
| RBR45 | In distribution | |
| EBR29-BV | In distribution | |
| REBR | In distribution | |
| BR32 | In distribution | |
| REBRN117S | In distribution | |
| REBRDYTA-20TB | In distribution | |
| REBRYWESCO | In distribution | |
| BR43 | In distribution | |
| REBR27S-28 | In distribution | |
| CEBR42 | In distribution | |
| CEBR27T-29 | In distribution | |
| BR42 | In distribution | |
| CHP3A-BR3 | In distribution | |
| REPFI21-BR29 | In distribution | |
| REBR43 | In distribution | |
| CEBR27S-29 | In distribution | |
| BR26-30 | In distribution | |
| REBR28-28 | In distribution | |
| REBR43T | In distribution | |
| REBRN117T | In distribution | |
| REBR29-BV | In distribution | |
| BR27-29 | In distribution | |
| CEBR27T-29 | In distribution | |
| BR26-29 | In distribution | |
| REBR3T-CHP2T | In distribution | |
| REPFI20-BR29 | In distribution | |
| BR21B | In distribution | |
| CEBR27S-2 | In distribution | |
| REBR21BLT | In distribution | |
| RBR43 | In distribution | |
| REBRDYTA-29TA | In distribution | |
| *BR | In distribution | |
| BR* | In distribution | |
| REBRN117 | Length 6.5 in | In distribution |
| BR28-29 | In distribution | |
| EBR42 | In distribution | |
| BR29-BV | In distribution | |
| REBR27-29T | In distribution | |
| BR21BL | In distribution | |
| RECN23T | In distribution | |
| BR28-PFI6T | In distribution | |
| REBR27S-29 | In distribution | |
| EBR43 | In distribution | |
| REBRDILLY | In distribution | |
| BV2 | In distribution | |
| REPFI39A-29 | In distribution | |
| CEBRLAD-3T | Length 6.5 in | In distribution |
| REBRN117A-117SB | In distribution | |
| REBR27S-29T | In distribution | |
| RECNBRYMORT | In distribution | |
| EBRPCST | In distribution | |
| EBRPCST | In distribution | |
| REBR26-29 | In distribution | |
| CEBR21BT | Length 6.5 in | In distribution |
| REBRLAD-3T | In distribution | |
| BSH0514N | In distribution | |
| REBR35 | In distribution | |
| BR25-PKT3L | In distribution | |
| BUR180 | In distribution | |
| REBR27-29 | In distribution | |
| REBRN117ST | In distribution | |
| RBRLAD-3 | In distribution | |
| REBR42 | In distribution | |
| REBR27-28 | In distribution | |
| CEBR27-29 | In distribution | |
| CEBRLAD-3T | In distribution | |
| CEBRN117S | In distribution | |
| BR26-BV | In distribution | |
| BRN117 | In distribution | |
| REBR26-28 | In distribution | |
| CEBR43 | In distribution | |
| BRLUCRK | In distribution | |
| CEBR25-29 | In distribution | |
| REBR21B | In distribution | |
| CEBR28-29 | In distribution | |
| BRBV | In distribution | |
| RPFI1101308 | Length 6.5 in | In distribution |
| REBR21BL | In distribution | |
| BR25-29 | In distribution | |
| CEBR21BL | In distribution | |
| REBRDILLYT | In distribution | |
| CEBR45 | In distribution | |
| CEBRN117ST | In distribution | |
| EBR21BL | In distribution | |
| REPFI39A-28 | In distribution | |
| REBR3-28 | In distribution | |
| EBR21B | In distribution | |
| EBR43 | In distribution | |
| RBR42 | In distribution | |
| CEBR32 | In distribution | |
| BR3-5 | In distribution | |
| BR26-27S | In distribution | |
| REBR42T | In distribution | |
| BRN117S | In distribution | |
| EBR27S-29 | In distribution | |
| BRLAD-3 | In distribution | |
| CEBR27-29T | In distribution | |
| BRDILLYT | In distribution | |
| CEBRLAD-3 | In distribution | |
| CEBRN117T | In distribution | |
| BR27S-29 | In distribution | |
| BRDILLY | In distribution | |
| REPFI21T-BR29 | In distribution | |
| EBR21BL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 58 |
| Power Dental USA | Power Dental U.S.A. Inc. | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 24 |
| J & J Instruments Inc | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 21 |
| Zoll-Dental | Zoll-Dental | 16 |
| PDT, Inc. | PDT, Inc. | 14 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 14 |
| Henry Schein | Henry Schein, Inc. | 7 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 5 |
| Burkhart Dental | Nordent Manufacturing Inc | 5 |
Showing 12 of 54. All products under Burnisher, Operative
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.