Hot Testing Tip
Hot Testing Tip: 2 catalogue numbers listed by B&L Biotech Co., Inc., South Korea, under Plugger, Root Canal, Endodontic. 19 manufacturers in China are registered for this product code.
19manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | B&L Biotech Co., Inc., South Korea |
|---|---|
| FDA product code | EKR |
| Device type | Plugger, Root Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HHTT | In distribution | |
| HTT | 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 |
| Obtura Spartan | Young Innovations Inc. | 25 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 22 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 22 |
Showing 12 of 136. All products under Plugger, Root Canal, Endodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060347 | 2006-06-05 |
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.