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SURE DENT CORPORATION

South Korea·KR-MF-000018662

Last updated September 17, 2026

What SURE DENT CORPORATION makes

Sure Dent Corporation manufactures non-medicated gingival retraction cords, including variants like the R&S Retraction Cord, Kent dental Retraction Cord, and Inline-Cord. These products are designed to isolate gingival tissue during dental procedures, such as impressions or restorations, to improve accuracy and margin definition.

The company’s portfolio includes devices classified as Class I and Class IIa under EU regulations, with products registered in the EUDAMED database. The manufacturer is based in South Korea.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sure Dent Corporation manufacture?

Sure Dent Corporation specializes in non-medicated gingival retraction cords, such as the R&S Retraction Cord, Kent dental Retraction Cord, and Inline-Cord. These devices are used in dentistry to temporarily retract gum tissue during procedures like impressions or restorations, ensuring clearer margins and better accuracy.

Where is Sure Dent Corporation based?

Sure Dent Corporation is headquartered in South Korea. The company’s location influences its regulatory compliance, particularly for markets like the European Union, where its devices are registered in the EUDAMED database.

Which regulatory registries list Sure Dent Corporation’s devices?

Sure Dent Corporation’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry allows healthcare professionals and regulators to verify the manufacturer’s details and device classifications.

How are Sure Dent Corporation’s devices classified under EU regulations?

Sure Dent Corporation’s devices fall into Class I and Class IIa classifications under EU medical device regulations. The classification depends on factors like the device’s intended use and potential risk level—gingival retraction cords are generally lower-risk but may require additional scrutiny depending on design or materials.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
South Korea
Address
52, #809, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
LinkedIn
—
Facebook
—
Phone
+82 31 737 4720
PRRC Contact
Sungjun Charles Bae
EUDAMED SRN
KR-MF-000018662
FDA FEI Number
3001421500
DUNS Number
—

Catalogue (1042)

Page 17 of 21
DeviceModel / ReferenceRegistriesClassStatus
EndoSequence® BC PointsTM Bioceramic Gutta Percha 5023080EU
EUDAMED
Class IIaActive
FQ Paper Points PPFQ04.000.045
EUDAMEDFDA UDI
Class IIaActive
Gutta Percha Points G906 40.06
EUDAMEDFDA UDI
Class IIaActive
Gutta Percha Points G906 70.06
EUDAMEDFDA UDI
Class IIaActive
Paper Points PRED Pointes de papier sterile 67140
EUDAMED
Class IIaActive
Direct Paper Points 200092
EUDAMED
Class IIaActive
Edge Taper Gutta Percha Points ETGPF2-1
EUDAMEDFDA UDI
Class IIaActive
Apol® Pointes Gutta B56832
EUDAMED
Class IIaActive
Direct Gutta Percha Points 200024
EUDAMED
Class IIaActive
F360® Guttapercha Points GPF04.000.045
EUDAMED
Class IIaActive
Absorbent Paper Points P920 L45.02
EUDAMED
Class IIaActive
Rachelendo Gutta Percha Points G906 L20.06
EUDAMED
Class IIaActive
Gutta Percha Points G712 15-40/.02
EUDAMED
Class IIaActive
Gutta Percha Points G812 55.02
EUDAMED
Class IIaActive
Gutta Percha Point G912 L90.02
EUDAMED
Class IIaActive
Absorbent Paper Points P910 LWG/L
EUDAMED
Class IIaActive
Gutta-Percha Points 24027
EUDAMEDFDA UDI
Class IIaActive
Rachelendo Gutta Percha Points G906 L55.04
EUDAMED
Class IIaActive
PlanBDental® minikut® Paper Points 1670340
EUDAMEDFDA UDI
Class IIaActive
Septodont Paper Points 12863H
EUDAMED
Class IIaActive
Sure-Cord Plus SCP-00 /S50
EUDAMEDFDA UDI
Class IIaActive
Steriblue Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper SB-PP4TP020
EUDAMED
Class IIaActive
Absorbent Paper Points P812 100.02
EUDAMED
Class IIaActive
Wellsamed Paper Points WPP370 ISO70 Gruen
EUDAMED
Class IIaActive
Paper Points PRED Pointes de papier sterile 67107
EUDAMED
Class IIaActive
Procodile® Guttapercha Points GPPR06.000.020
EUDAMEDFDA UDI
Class IIaActive
Absorbent Paper Points P720 40.02
EUDAMED
Class IIaActive
Edge File X7 .04 Gutta Percha Points X71704GP-1
EUDAMEDFDA UDI
Class IIaActive
Absorbent Paper Points P312 110.02
EUDAMED
Class IIaActive
F6 SkyTaper® Paper Points PPF06.000.S1
EUDAMED
Class IIaActive
Paper Points 25902
EUDAMEDFDA UDI
Class IIaActive
Direct Paper Points 200062
EUDAMED
Class IIaActive
Paper Points PP02.000.015
EUDAMED
Class IIaActive
Wellsamed Guttapercha Points WGP335 ISO35 Gruen
EUDAMED
Class IIaActive
Gutta-Percha Points 24055
EUDAMEDFDA UDI
Class IIaActive
Bio GP Points G906 LB20-45.05
EUDAMED
Class IIaActive
Edge Taper Gutta Percha Points ETGPF4-1
EUDAMEDFDA UDI
Class IIaActive
Apol® Pointes Papier B56355
EUDAMED
Class IIaActive
F6 SkyTaper® Paper Points PPF06.000.030
EUDAMED
Class IIaActive
Sendoline® Paper Points 4000306
EUDAMED
Class IIaActive
Gutta Percha Points G906 30.06
EUDAMEDFDA UDI
Class IIaActive
Paper Points 25955
EUDAMEDFDA UDI
Class IIaActive
Gutta Percha Points G912 100.02
EUDAMEDFDA UDI
Class IIaActive
Gutta-Percha Points 24024
EUDAMEDFDA UDI
Class IIaActive
Absorbent Paper Points P910 35.06
EUDAMEDFDA UDI
Class IIaActive
F360® Paper Points PPF04.000.S1
EUDAMED
Class IIaActive
EndoSequence® BC PointsTM Bioceramic Gutta Percha 5023081EU
EUDAMED
Class IIaActive
Gutta Percha Points G906 L30.06
EUDAMED
Class IIaActive
Edge File X7 .06 Gutta Percha Points X74006GP-1
EUDAMEDFDA UDI
Class IIaActive
Gutta Percha Points G812 80.02
EUDAMED
Class IIaActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Sure Dent Corporation US