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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
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 18 of 21

Device	Model / Reference	Registries	Class	Status
Bio GP Points	G906 LBF4	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 55.04	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P920 45-80/.02	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 BF1	EUDAMEDFDA UDI	Class IIa	Active
Centra® Endo Paper	SD5125	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 L25.06	EUDAMED	Class IIa	Active
Direct Paper Points	200070	EUDAMED	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600340	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25947	EUDAMEDFDA UDI	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1640	EUDAMED	Class IIa	Active
Direct Bioceramic Gutta Percha	200044	EUDAMED	Class IIa	Active
Edge Taper Paper Points	ETPPF3-1	EUDAMEDFDA UDI	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600540	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25982	EUDAMEDFDA UDI	Class IIa	Active
CrownTaper GuttaPercha Points	122F3	EUDAMED	Class IIa	Active
Gutta Percha Obturator	Soft	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 40.04	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25950	EUDAMEDFDA UDI	Class IIa	Active
Edge One R Gutta Percha Points	EORGP35-1	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P912 140.02	EUDAMEDFDA UDI	Class IIa	Active
F360® Paper Points	PPF04.000.035	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP49/20	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/15	EUDAMED	Class IIa	Active
Kono® Gutta Percha Points	BP42/30	EUDAMED	Class IIa	Active
F6 SkyTaper® Paper Points	PPF06.000.040	EUDAMED	Class IIa	Active
Bio Gutta Percha Points Isi-ENDO	67118	EUDAMED	Class IIa	Active
Rachelendo Paper Points	P920 L15-40/.02	EUDAMED	Class IIa	Active
Mynol® Absorbent paper Points	MY-01346	EUDAMED	Class IIa	Active
Absorbent Paper Points	P320 55.02	EUDAMED	Class IIa	Active
FQ Guttapercha Points	GPFQ04.000.030	EUDAMEDFDA UDI	Class IIa	Active
Paper Points	25904	EUDAMEDFDA UDI	Class IIa	Active
Centra® Endo Gutta	SD50FF	EUDAMED	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.10ASP	EUDAMED	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5019520EU	EUDAMED	Class IIa	Active
Edge File X7 .04 Gutta Percha Points	X72504GP-1	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 50.04	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 B90.04	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI04 30	EUDAMED	Class IIa	Active
Bio GP Points	G912 LB55.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 20.04	EUDAMEDFDA UDI	Class IIa	Active
Kono® Gutta Percha Points	BP42/35	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 L45.06	EUDAMED	Class IIa	Active
XP-4D ® Absorbent Paper Points	08.610.03.040.BC	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI06 45	EUDAMED	Class IIa	Active
Kono® Absorbent Paper Points	BP40/15	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G912 L20.02	EUDAMED	Class IIa	Active
Absorbent Paper Points	P912 90-140/.02	EUDAMEDFDA UDI	Class IIa	Active
EdgeOne Fire Paper Points	EOFPRIPP-1	EUDAMEDFDA UDI	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600530	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 60.06	EUDAMEDFDA UDI	Class IIa	Active

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FDA Establishments (1)

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

Sure Dent Corporation US