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Y-Kelin®

EUDAMEDFDA UDI

Class I (EU MDR)

Ref N/AModel 10g/box，25g/box, 40g/box，70g/boxModel Upper： 24 pieces/box， 30 pieces/box Lower： 24 pieces/box， 30 pieces/boxRef 40g/box

by Anhui Greenland Biotech Co., Ltd

Identity

Trade Name
Y-Kelin® EUDAMED
Ortodont EUDAMED
Y-Kelin FDA UDI
Generic Name
Denture cushion FDA UDI
Karaya/acacia denture adhesive, high sodium borate FDA UDI
Device Name
Denture Adhesive Cream EUDAMED
Denture Adhesive Cushions EUDAMED
Products Name: Y-Kelin Denture Adhesive Cushion for Upper Dentures Specification: 30 pieces Composition: Sodium alginate, Polyester fiber, Viscose fiber Applicable People: For complete dentures. Products Features: Increase the absorbability of the removable denture and the alveolar ridge. Extra strong secure hold. Does not affect taste. Directions: 1. Clean and moisten the dentures. 2.If the cushion is too large, cut the cushion to appropriate with scissor, keep in mind that leaving the denture margin of 2mm, Do not cover. 3. Moisten the adhesive cushion in warm water, place and press it on the denture. Press the cushion with two thumbs from the denture center to the sides, until the cushion is completely flat docile. 4 . Place dentures into mouth. Hold firmly until secure. Caution: If irritation occurs, discontinue use. The products can not be resued. Keep out of reach of children. Allergy caution. Store: A dark and dry place. Expiry date: in 36 months FDA UDI
Product Name: Y-kelin Adhesive Cream for Upper and Lower Dentures. Specification:40g. Main Ingredient: Calcium Sodium PVM/MA Copolymer, Carboxymethyl cellulose,Methyl-p-hydroxy benzoate, Vaseline, Paraffin, Silica, Menthol, Azorubin.Does not contain Zinc. Applicable People: For complete dentures. Directions: 1.Clean and dry your dentures thoroughly. 2.Apply the cream to either wet or dry dentures. 3.Squeeze the cream from the bottcom of the tube. It is better to flatten the tube and not roil it. 4. Apply the cream to your dentures in strips (as shown in the diagram) or series of dots, making sure that the cream is not too close to the edge of the denture. 5.Insert denture into mouth and bite firmly. 6. For best results wait 15 minutes, before eating or drinking Expiry date: in 36 months. FDA UDI
Model / Reference
10g/box，25g/box, 40g/box，70g/box EUDAMED
N/A EUDAMED
Upper： 24 pieces/box， 30 pieces/box Lower： 24 pieces/box， 30 pieces/box EUDAMED
40g/box EUDAMEDFDA UDI
30 pads FDA UDI
Description
Products Name: Y-Kelin Denture Adhesive Cushion for Upper Dentures Specification: 30 pieces Composition: Sodium alginate, Polyester fiber, Viscose fiber Applicable People: For complete dentures. Products Features: Increase the absorbability of the removable denture and the alveolar ridge. Extra strong secure hold. Does not affect taste. Directions: 1. Clean and moisten the dentures. 2.If the cushion is too large, cut the cushion to appropriate with scissor, keep in mind that leaving the denture margin of 2mm, Do not cover. 3. Moisten the adhesive cushion in warm water, place and press it on the denture. Press the cushion with two thumbs from the denture center to the sides, until the cushion is completely flat docile. 4 . Place dentures into mouth. Hold firmly until secure. Caution: If irritation occurs, discontinue use. The products can not be resued. Keep out of reach of children. Allergy caution. Store: A dark and dry place. Expiry date: in 36 months FDA UDI
Product Name: Y-kelin Adhesive Cream for Upper and Lower Dentures. Specification:40g. Main Ingredient: Calcium Sodium PVM/MA Copolymer, Carboxymethyl cellulose,Methyl-p-hydroxy benzoate, Vaseline, Paraffin, Silica, Menthol, Azorubin.Does not contain Zinc. Applicable People: For complete dentures. Directions: 1.Clean and dry your dentures thoroughly. 2.Apply the cream to either wet or dry dentures. 3.Squeeze the cream from the bottcom of the tube. It is better to flatten the tube and not roil it. 4. Apply the cream to your dentures in strips (as shown in the diagram) or series of dots, making sure that the cream is not too close to the edge of the denture. 5.Insert denture into mouth and bite firmly. 6. For best results wait 15 minutes, before eating or drinking Expiry date: in 36 months. FDA UDI

Identifiers

Primary DI / UDI-DI
06943566100187 EUDAMEDFDA UDI
06943566100095 EUDAMEDFDA UDI
06943566120109 EUDAMED
Basic UDI-DI
69435661Denture002RY EUDAMED
69435661Denture001RW EUDAMED
FDA Product Code
EHS FDA UDI
KOT FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Denture cushion FDA UDI
Karaya/acacia denture adhesive, high sodium borate FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class II FDA UDI
Regulation Number
872.3540 FDA UDI
872.3490 FDA UDI
Market of Registration
Germany EUDAMED
Italy EUDAMED
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDIFDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anhui Greenland Biotech Co., Ltd
EUDAMED SRN
CN-MF-000026195
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (6)

  • EUDAMED ba3e8356-8d5a-49f0-8147-d8a6b1b076cc 61 fields · synced Jul 23, 2026
  • EUDAMED 462af7ba-4b32-4e11-8c39-39914c028a9c 61 fields · synced May 18, 2026
  • EUDAMED e1680efc-b010-4175-9502-af0e7626f801 61 fields · synced May 18, 2026
  • FDA UDI c33cb832-63f9-4879-995c-3349a1b28c1f 34 fields · synced May 30, 2026
  • FDA UDI 3c43daf1-3fa4-4995-a796-c41e2be6f969 33 fields · synced May 30, 2026
  • EUDAMED ba3e8356-8d5a-49f0-8147-d8a6b1b076cc-1 61 fields · synced Jul 22, 2026