AccessGUDID - DEVICE: Y-Kelin (06943566100514)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Kelin
Version or Model: 12 Tablets
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANHUI GREENLAND BIOTECH CO.,LTD

Primary DI Number: 06943566100514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 544396491 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60408	Dental caries detecting stain	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJR	Erythrosin B

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8bc70c1e-7a9a-44f3-8e25-0aa939dfb2a8
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022