Y-Kelin

Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biotech Co., Ltd Address:No.5, Kaiyuan Rd,Mchekou Industrial Zone, Huaishang District,Bengbu,…

Registry build 21.09.26

Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biotech Co., Ltd Address:No.5, Kaiyuan Rd,Mchekou Industrial Zone, Huaishang District,Bengbu, Anhui,China Tel:0552-5875300 Product performance:Used to show plaquue, assist oral examination and treatment Main ingredients:Erythrosine, Blue No.1 AluminumLake, Glucose, Silica, PEG-180, Magnesium Stearate, Spices Scope of application:Suitable for peoplewho are expected to show dental plaque Contraindications: 1.People who are allergic to ingredients are prohibited to use. 2.Do not swallow directly. 3.Use with caution for pregnant women and infants. Instructions: 1.Take a piece of plaque indicator into your mouth and chew it, lick it with the tip of your tongue to the inside and outside of the entire tooth surface, and hold it in your mouth for about 1 minute. 2.Spit out the residue in your mouth and rinse your mouth with water. 3. Check the oral cavity with a mirror, the stained part of the tooth surface is the part where the plaque is attached. Store: This product is stored in a ventilated and dry place at room temperature. Transportation conditions/methods:Transportation conditions and methods must meet the requirements of the instructions and signs. Period of use: Three years.

34manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Jiangsu (8), Jiangxi (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EFT
Manufacturer City Province Registered as Device types
Shenzhen Moye Technology Co Ltd Shenzhen Guangdong Contract manufacturer 14
Jiangxi Dentalbright Technology Co., Ltd. Jiujiang Jiangxi Contract manufacturer 12
Yangzhou Star Oral Care Product Co., Ltd. Yangzhou Jiangsu Contract manufacturer 7
Kingkey MBC Life Technology Group Co., Ltd. Shantou Guangdong Contract manufacturer 6
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Planet(Shanghai) International Co., Ltd. Shanghai Shanghai Exporter 93
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
Cangzhou Lankang Medical Instruments Developing Co., Ltd. Cangzhou Hebei Manufacturer 40
Guangdong Xinuo Personal Care Products Co., Ltd. Yunfu Guangdong Manufacturer 33
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Tianjin Water Source Tech Co., Ltd. Tianjin Tianjin Manufacturer 27

Showing 12 of 34. All 34 manufacturers in China registered for Cleanser, Denture, Over The Counter

Record

Regulatory record for Y-Kelin
Listed by Anhui Greenland Biotech Co., Ltd., China
FDA product code EFT
Device type Cleanser, Denture, Over The Counter
Device class Class 1
Regulation 21 CFR 872.3520
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-12-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Y-Kelin
Catalogue number Size Per pack Status
36 Tablets 36 In distribution
30 Tablets 30 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Retainer Brite® Dentsply Sirona Orthodontics Inc. 10
Ola Fresh Dental Appliance Cleanser Thermoplastic Comfort SYS 3
TCS Fresh Concentrated Dental Appliance Cleaner Thermoplastic Comfort SYS 3
Smilesaver Soluria II LLC 3
Cleaning Crystals, Packette Align Technology, Inc. 2
DawnMist Dukal LLC 2
Pala Kulzer SRL 2
Freshmint NEW World Imports, Inc. 2
Venus Kulzer SRL 2
Efferdent Medtech Products, Inc. 2
Dentasoak KIT-NO CUP(3 Months) Great Lakes Dental Technologies, Ltd. 1
BrightByte Straight Smile, LLC 1

Showing 12 of 46. All products under Cleanser, Denture, Over The Counter

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