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Y-Kelin

FDA UDI

Class I (US FDA UDI)

by Anhui Greenland Biotech Co., Ltd

Identity

Trade Name
Y-Kelin FDA UDI
Generic Name
Dental caries detecting stain FDA UDI
Device Name
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. FDA UDI
Model / Reference
12 Tablets FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
06943566100514 FDA UDI
FDA Product Code
KJR FDA UDI
GMDN Term
Dental caries detecting stain FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental caries detecting stain

Y-Kelin by Anhui Greenland Biotech Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental caries detecting stain.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anhui Greenland Biotech Co., Ltd

Sources (1)

  • FDA UDI 8bc70c1e-7a9a-44f3-8e25-0aa939dfb2a8 33 fields · synced May 30, 2026