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…

Registry build 21.09.26

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.

14manufacturers in China registered for this device type
31catalogue numbers in this listing
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code ELC
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

Regulatory record for TUN Ultrasonic Tip
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

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for TUN Ultrasonic Tip
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer