Obtura Spartan
Obtura III Max Thermal Protectors, 4 pack
19manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 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 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
Showing 12 of 19. All 19 manufacturers in China registered for Plugger, Root Canal, Endodontic
Record
| Listed by | Young Innovations Inc., United States |
|---|---|
| FDA product code | EKR |
| Device type | Plugger, Root Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K060347 |
| Record published | 2022-10-06 |
| Record revised | 2022-12-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Package, inner pack, package of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 823-810 | In distribution | |
| 823-803 | In distribution | |
| 824-504 | In distribution | |
| 823-620 | In distribution | |
| 824-706 | In distribution | |
| 824-712 | In distribution | |
| 824-711 | In distribution | |
| 823-812 | In distribution | |
| 823-815 | In distribution | |
| 823-623 | In distribution | |
| 824-502 | In distribution | |
| 824-700 | In distribution | |
| 823-800 | In distribution | |
| 824-714 | In distribution | |
| 824-715 | In distribution | |
| 823-635 | In distribution | |
| 824-716 | In distribution | |
| 824-713 | In distribution | |
| 823-610 | In distribution | |
| 823-813 | In distribution | |
| 824-503 | In distribution | |
| 823-804 | In distribution | |
| 824-507 | In distribution | |
| 824-717 | In distribution | |
| 824-505 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 268 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 93 |
| Power Dental USA | Power Dental U.S.A. Inc. | 82 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 69 |
| Needle | B&L Biotech Co., Inc. | 40 |
| American Eagle Instruments | American Eagle Instruments | 33 |
| Henry Schein | Henry Schein, Inc. | 33 |
| Premier Pluggers | Premier Dental Products Co. | 29 |
| EQ-V | Meta Systems Co., Ltd. | 26 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 22 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 22 |
| Edge Endo | Handpiece Parts & Repairs, Inc. | 21 |
Showing 12 of 136. All products under Plugger, Root Canal, Endodontic
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.