TUN Ultrasonic Tip
TUN Ultrasonic Tips are attachments for piezoelectric ultrasonic handpieces and scaler units used by dental professionals during root canal preparation. They remove soft and hard tissue and…
TUN Ultrasonic Tips are attachments for piezoelectric ultrasonic handpieces and scaler units used by dental professionals during root canal preparation. They remove soft and hard tissue and can assist with removal of endodontic posts and other blockages within the canal.
The stainless steel tips transmit vibration from the connected powered unit. Six tip designs accommodate different canal angles and directions, including a design for post removal. M3x0.5 and M3x0.6 threaded connections are available for compatible handpieces.
Preparation and Handling
The tips are supplied nonsterile and require cleaning and steam sterilization before each use. Damaged or distorted tips should be discarded. The tip must be securely attached, and continuous contact should not exceed 30 seconds to limit overheating of dentin.
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (4), Shandong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| China Zhong YAN Chang Xing International Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Nanning Baolai Medical Instrument Co., Ltd. | Nanning | Guangxi | Manufacturer | 4 |
Showing 12 of 14. All 14 manufacturers in China registered for Scaler, Ultrasonic
Record
| Listed by | Engineered Endodontics, United States |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| 510(k) | K182145 |
| Record published | 2026-01-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GB2 | In distribution | |
| GB3 | In distribution | |
| FRR-7 | In distribution | |
| E5 | In distribution | |
| GK3D | In distribution | |
| GC5D | In distribution | |
| E3 | In distribution | |
| GB2A | In distribution | |
| GK4D | In distribution | |
| E1 | In distribution | |
| GK1D | In distribution | |
| GB1A | In distribution | |
| GB1-90 | In distribution | |
| E2 | In distribution | |
| GB3A | In distribution | |
| GC4D | In distribution | |
| GK6D | In distribution | |
| GC3D | In distribution | |
| GK2D | In distribution | |
| GB1-110 | In distribution | |
| FRR-6 | In distribution | |
| FRR-8 | In distribution | |
| R2 | In distribution | |
| E6 | In distribution | |
| GC1 | In distribution | |
| R1 | In distribution | |
| GB1 | In distribution | |
| R3 | In distribution | |
| GC2D | In distribution | |
| E4 | In distribution | |
| GK5D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 501 |
| Piezon | E.M.S. Electro Medical Systems S.A. | 245 |
| Acteon | Satelec | 236 |
| Mectron | Mectron SPA | 209 |
| Varios | Nakanishi Inc. | 158 |
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 142 |
| Cavitron® | Dentsply Professional | 137 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 113 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 83 |
| Obtura Spartan | Obtura Spartan Endodontics | 74 |
| Henry Schein | Henry Schein, Inc. | 48 |
| Baolai | Nanning Baolai Medical Instrument Co., Ltd. | 46 |
Showing 12 of 653. All products under Scaler, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182145 | 2019-06-07 |
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.