Is this your brand? Sign in to claim ownership.

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
Website: www.suredent.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 31 737 4720
PRRC Contact: Sungjun Charles Bae
EUDAMED SRN: KR-MF-000018662
FDA FEI Number: 3001421500
DUNS Number: —

Catalogue (1042)

Page 15 of 21

Device	Model / Reference	Registries	Class	Status
EdgeOne Fire Gutta Percha Points	EOFSMGP-1	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 L70.06	EUDAMED	Class IIa	Active
Edge One R Gutta Percha Points	EORGP20-1	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G912 LB15-40/.02	EUDAMED	Class IIa	Active
Guttapred Pointes de Gutta Percha	67125	EUDAMED	Class IIa	Active
Procodile® Paper Points	PPPR06.000.020	EUDAMEDFDA UDI	Class IIa	Active
Inline® Absorbent Paper Points	IP46/15-40	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 130.02	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G912 L45-80/.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P920 50.02	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 45.04	EUDAMEDFDA UDI	Class IIa	Active
XP-4D ® Bio GP Cones	08.600.03.045.RE	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP49/90	EUDAMED	Class IIa	Active
Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper	SB-PG4TPASS	EUDAMED	Class IIa	Active
Wellsamed Paper Points	WPP401 ISO20-45 Sortiert	EUDAMED	Class IIa	Active
F6 SkyTaper® Guttapercha Points	GPF06.000.030	EUDAMED	Class IIa	Active
Apol® Pointes Gutta	B55335	EUDAMED	Class IIa	Active
Wellsamed Paper Points	WPP615 ISO15 Weiss	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 45.02	EUDAMEDFDA UDI	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5022678EU	EUDAMED	Class IIa	Active
Apol® Pointes Gutta	B55035	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 L15-40/.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P720 80.02	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB40.05	EUDAMEDFDA UDI	Class IIa	Active
Gutta-Percha Points	24034	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 20.06	EUDAMEDFDA UDI	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023127EU	EUDAMED	Class IIa	Active
Apol® Pointes Gutta	B55385	EUDAMED	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1635	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023115EU	EUDAMED	Class IIa	Active
Sure-Seal RootTM Bio GP Points	G912 CS55.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 20-45/.06	EUDAMEDFDA UDI	Class IIa	Active
CrownOne Paper Points	12035	EUDAMED	Class IIa	Active
Absorbent Paper Points	P820 50.02	EUDAMED	Class IIa	Active
Apol® Pointes Papier	B56245	EUDAMED	Class IIa	Active
Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper	SB-PG4TP035	EUDAMED	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600545	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P720 35.02	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/40-60	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 30.02	EUDAMEDFDA UDI	Class IIa	Active
Septodont Paper Points	12866K	EUDAMED	Class IIa	Active
Paper Points	25913	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 55.06	EUDAMEDFDA UDI	Class IIa	Active
Wieder® EndoGutta+	WI04 40	EUDAMED	Class IIa	Active
Gutta-Percha Points	24053	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G912 20.02	EUDAMEDFDA UDI	Class IIa	Active
Gutta-Percha Points	24011	EUDAMEDFDA UDI	Class IIa	Active
Direct Gutta Percha Points	200004	EUDAMED	Class IIa	Active
Sure-Seal RootTM Bio GP Points	G906 CS40.06	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB20.04	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Obelis s.a. BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Sure Dent Corporation US