Y-Kelin

Primary DI
06943566100514
Brand
Y-Kelin
Company
ANHUI GREENLAND BIOTECH CO.,LTD
Model
12 Tablets
Device description
Product Name:Plaque IndicatorSpecification:0.3g/piece*12/boxManufacturer:Anhui Greenland Biotech Co., LtdAddress:No.5, Kaiyuan Rd,Mchekou Industrial Zone, Huaishang District,Bengbu, Anhui,China Tel:0552-5875300Product performance:Used to show plaquue, assist oral examination and treatmentMain ingredients:Erythrosine, Blue No.1 AluminumLake, Glucose, Silica, PEG-180, Magnesium Stearate, SpicesScope of application:Suitable for peoplewho are expected to show dental plaqueContraindications: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.
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KJRErythrosin B

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJRErythrosin BHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06943566100514PrimaryGS10
16943566100511Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06943566100514069435661005146943566100514
1694356610051116943566100511

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detecting stainA liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544396491
Device count
12
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06943566100163Y-Kelin30 pads2019-04-19
06943566100118Y-Kelin30 Tablets2022-12-06
06943566107391Y-Kelin36 Tablets2022-12-06
16943566100115Y-Kelin30 Tablets2022-12-06
06943566100187Y-Kelin40g/Box2022-12-06
06943566100378Y-Kelin25g/Box2022-12-06
16943566107398Y-Kelin36 Tablets2022-12-06
06943566100095Y-Kelin30 pads2019-04-15
06943566100651Y-Kelinupper 30 pads + lower 30 pads2019-04-19
06943566100637Y-Kelin30 pads2019-04-15