Hygitech

Sterile irrigation set HYGITECH Reference: HY-110009 Packaging : Box of 10 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market.…

Registry build 21.09.26

Sterile irrigation set HYGITECH Reference: HY-110009 Packaging : Box of 10 HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer

128manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (65), Zhejiang (24), Jiangsu (9). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EFS
Manufacturer City Province Registered as Device types
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Providence Enterprise Limited Shenzhen Guangdong Contract manufacturer 9
Yangzhou Star Oral Care Product Co., Ltd. Yangzhou Jiangsu Contract manufacturer 7
HI-P (Xiamen) Precision Plastic Manufacturing Co., Xiamen Fujian Contract manufacturer 6
Yuyao Clean Commodity Co., Ltd. Yuyao Zhejiang Contract manufacturer 6
Xiamen Jieboya Technology Co., Ltd. Xiamen Fujian Contract manufacturer 5
Dongguan Shun King Company Limited Dongguan Guangdong Contract manufacturer 4
Runner (Xiamen) Corp. Xiamen Fujian Contract manufacturer 4
Zhejiang Beauty AND Health Electrical Appliance Co., Ltd. Wenzhou Zhejiang Contract manufacturer 3
Providence Enterprise (Ganzhou) Co., Ltd. Ganzhou Jiangxi Contract manufacturer 2
Fly Cat Electrical Co., Ltd. Shenzhen Guangdong Contract manufacturer 1

Showing 12 of 128. All 128 manufacturers in China registered for Unit, Oral Irrigation

Record

Regulatory record for Hygitech
Listed by Hygitech
FDA product code EFS
Device type Unit, Oral Irrigation
Device class Class 1
Regulation 21 CFR 872.6510
Premarket notification Exempt
Record published 2020-12-15
Record revised 2020-12-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 10, carton of 10, cartons of 10, cartons of 12, carton of 8

Catalogue Numbers

Catalogue numbers for Hygitech
Catalogue number Size Status
HY-110042 In distribution
HY-110028 In distribution
HY-110018 In distribution
HY-110011 In distribution
HY-110001 In distribution
HY-110034 In distribution
HY-12025 In distribution
HY-110014 In distribution
HY-110054 In distribution
HY-110005 In distribution
HY-110009 In distribution
HY-110007 In distribution
HY-110003 In distribution
HY-110022 In distribution
HY-12017 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Philips Sonicare Philips Oral Healthcare, LLC 46
Conair Conair LLC. 18
Cooskin Ningbo Cooskin Stationery Co., Ltd. 10
Waterpik Sonic-Fusion 2.0 Water PIK, Inc. 8
Dental Irrigation KIT Anchiplast SRL 8
Risuntech Shenzhen Risun Technology Co., Ltd. 7
Ordo Ordoclub Ltd 7
Waterpik Ultra Water Flosser Water PIK, Inc. 7
Waterpik Complete Care Oscillating 5.5 Water PIK, Inc. 6
Waterpik Cordless Pulse Water Flosser Water PIK, Inc. 6
Irrigation Line Omnia Medical 6
Waterpik Cordless Advanced Water Flosser Water PIK, Inc. 6

Showing 12 of 137. All products under Unit, Oral Irrigation

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