Who else makes this device?

Name: Sinus Lift Kit
Brand: Sinus Lift Kit

Sinus Lift Kit · Scaler, Ultrasonic → Dental

14manufacturers in China registered for this device type

1catalogue number

7510(k) clearances naming this product code

2recalls on this code

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 Sinus Lift Kit
Listed by	Nakanishi Inc., Japan
FDA product code	ELC
Device type	Scaler, Ultrasonic
Device class	Class 2
Regulation	21 CFR 872.4850
Establishment	Contract manufacturer, Manufacturer
510(k)	K073678
Record published	2016-09-16
Record revised	2026-04-17 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Sinus Lift Kit
Catalogue number	Size	Status
Sinus Lift Kit		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
K260773	2026-03-10
K251689	2025-09-19
K113717	2013-03-05
K113530	2013-01-31
K071447	2008-04-18
K062731	2007-05-01
K031421	2004-03-26

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Sinus Lift Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Nakanishi Inc.	510(k) number	2016-07-08	Class II	Error in labeling	Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are	2574 units	2018-06-25

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-07-08	Class II	Error in labeling	Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are	30719 units	2018-06-25

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.

Sinus Lift Kit