Caulk® Post & Core Kit
Catalogue number 61i000, listed by Dentsply LLC, United States, under Reamer, Pulp Canal, Endodontic. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EKP |
| Device type | Reamer, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-06-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry. |
| Distribution end date | 2024-06-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 61i000 | 15 Fiber Posts 2 Reamers 4 Drills 1 TCGel, 25 Tips, 1 bottle adhesive & activator 1 Mixing Well 2 syringes FluoroCore 10 Mix Tips and Endo Intraoral Tips 1 Mix Pad 30 Paper Points 50 Root Canal Tips | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 133 |
| Mani Reamers | Mani, Inc. | 106 |
| K-Reamers | Tulsa Dental Products LLC | 103 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 82 |
| K-Reamers | Micro-Mega SA | 72 |
| M-access® K-Reamer | Maillefer Instruments Holding Sàrl | 69 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Mani Engine Reamers | Mani, Inc. | 64 |
| Optimum | Benco Dental Supply Co. | 60 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 60 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 49 |
| SafeSiders | Essential Dental Systems, Inc. | 40 |
Showing 12 of 195. All products under Reamer, Pulp 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.