Who else makes this device?

Name: Y-Kelin
Brand: Y-Kelin

Dental › ProstheticAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)

Y-Kelin

Product Name:Y-kelin Denture Adhesive Powder. Composition: Sodium Alginate. Scope of applicable: Special denture adhesive, a temporary auxiliary denture retentive material. Product…

Registry build 21.09.26

Product Name:Y-kelin Denture Adhesive Powder. Composition: Sodium Alginate. Scope of applicable: Special denture adhesive, a temporary auxiliary denture retentive material. Product Features: Supper extra strength keeps dentures secure. Easy to use.No added colors and flavor,does not affect taste. Directions: 1.Clean and moisten your dentures thoroughly. 2.Tilt the powder bottle mouth towards the denture support, gently tap on the bottle body by index finger, then evenly spray the appropriate adhesive powder to the surface of the denture support. 3. Insert denture into mouth and bite firmly for several seconds. Applicable People: For complete dentures. Store: keep in cool and dry place. Specification: 25g Expiry date: in 24 months. Manufacturer: Anhui Greenland Biotech Co.,Ltd. Add: Mohekou Industrial Zone, Bengbu, Anhui, China. Tel:0552-5875300

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Hebei (1), Shanghai (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code KOQ
Manufacturer	City	Province	Registered as	Device types
Debo Medical Technology (Shijiazhuang) Co., Ltd.	Shijiazhuang	Hebei	Contract manufacturer	117
Shanghai MU Promotions Co., Ltd.	Shanghai	Shanghai	Exporter	62
Tribest Dental Products Co Ltd	Yangzhong	Jiangsu	Contract manufacturer	58
Anhui Greenland Biotech Co., Ltd.	Bengbu	Anhui	Manufacturer	6

Record

Regulatory record for Y-Kelin
Listed by	Anhui Greenland Biotech Co., Ltd., China
FDA product code	KOQ
Device type	Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Device class	Class 1
Regulation	21 CFR 872.3410
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	Status
25g/Box		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Secure Denture Cushion Strips	Fittydent Intl. Gmbh	1

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.