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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 11 of 21

Device	Model / Reference	Registries	Class	Status
Gutta Percha Points	G906 60.04	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P720 30.02	EUDAMED	Class IIa	Active
Paper Points	25976	EUDAMEDFDA UDI	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/15-35	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR05.000.035	EUDAMEDFDA UDI	Class IIa	Active
Direct Paper Points	200058	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP04/40	EUDAMED	Class IIa	Active
Absorbent Paper Points	P920 45.02	EUDAMEDFDA UDI	Class IIa	Active
Bio Gutta Percha Points Isi-ENDO	67127	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-1/S50	EUDAMEDFDA UDI	Class I	Active
Absorbent Paper Points	P910 L55.04	EUDAMED	Class IIa	Active
Gutta-Percha Points	24029	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G912 LB90-140/.02	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 20-45/.04	EUDAMEDFDA UDI	Class IIa	Active
Inline® Absorbent Paper Points	IP51S/30	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP50/L	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 L60.02	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP06/40	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 10.04	EUDAMED	Class IIa	Active
Sure-Seal RootTM Bio GP Points	G906 CS15.06	EUDAMED	Class IIa	Active
Edge Taper Paper Points	ETPPAST-1	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LB70.04	EUDAMED	Class IIa	Active
CrownTaper GuttaPercha Points	122F4	EUDAMED	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600335	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G912 L110.02	EUDAMED	Class IIa	Active
Septodont Gutta Percha	12851V	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 L40.06	EUDAMED	Class IIa	Active
B-4U Gutta Percha Points	G906 LBF12/Finisher M	EUDAMEDFDA UDI	Class IIa	Active
Mynol® Gutta Percha Points	MY-01262	EUDAMED	Class IIa	Active
Paper Points	25903	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 80.04	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P912 L140.02	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-2	EUDAMEDFDA UDI	Class I	Active
Absorbent Paper Points	P912 90.02	EUDAMEDFDA UDI	Class IIa	Active
Direct Bioceramic Gutta Percha	200031	EUDAMED	Class IIa	Active
Bio GP Points	G906 LBWG/L	EUDAMED	Class IIa	Active
PlanBDental® minikut® Gutta Percha Points	1600515	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G912 L25.02	EUDAMED	Class IIa	Active
FQ Paper Points	PPFQ06.000.020	EUDAMEDFDA UDI	Class IIa	Active
Apol® Pointes Gutta	B55155	EUDAMED	Class IIa	Active
Sure-Cord Clean	SCC-00/S50	EUDAMEDFDA UDI	Class I	Active
Centra® Endo Paper	SD5180	EUDAMED	Class IIa	Active
EdgeEndo .04 Paper Points	SPP3504-1	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Gutta Percha Points	G906 L80.04	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP49/70	EUDAMED	Class IIa	Active
Gutta-Percha Points	24041	EUDAMEDFDA UDI	Class IIa	Active
Wieder® EndoPaper+	WI51 55	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 F5	EUDAMEDFDA UDI	Class IIa	Active
Septodont Gutta Percha	12854Y	EUDAMED	Class IIa	Active
PlanBDental® minikut® Paper Points	1670330	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