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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 19 of 21

Device	Model / Reference	Registries	Class	Status
Bio GP Points	G906 LB1.0F20.06	EUDAMED	Class IIa	Active
Bio GP Points	G906 B60.04	EUDAMED	Class IIa	Active
Gutta-Percha Points	24002	EUDAMEDFDA UDI	Class IIa	Active
Wieder® EndoGutta+	WI50 ML	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP49/25	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 15.04	EUDAMEDFDA UDI	Class IIa	Active
Wieder® EndoGutta+	WI06 35	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 20.06	EUDAMEDFDA UDI	Class IIa	Active
Septodont Gutta Percha	12842M	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM 150 Series Bioceramic Gutta Percha	5027289EU	EUDAMED	Class IIa	Active
Guttapred Pointes de Gutta Percha	67110	EUDAMED	Class IIa	Active
Septodont Gutta Percha	12847R	EUDAMED	Class IIa	Active
Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper	SB-PGVTF3	EUDAMED	Class IIa	Active
Wellsamed Paper Points	WPP355 ISO55 Rot	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP40/40	EUDAMED	Class IIa	Active
Rachelendo Paper Points	P910 L15.06	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB1.0F35.06	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI49 20	EUDAMED	Class IIa	Active
Bio GP Points	G912 LB130.02	EUDAMED	Class IIa	Active
Gutta Percha Points	G812 90-140/.02	EUDAMED	Class IIa	Active
Gutta-Percha Points	24001	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LBWG/M	EUDAMED	Class IIa	Active
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper	PL-SEP-33E.0425	EUDAMED	Class IIa	Active
Exotec Pointes de Gutta Percha, ISO Color, ISO Taper	EN02420	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 L10.02	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023132EU	EUDAMED	Class IIa	Active
Direct Paper Points	200067	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 30.06	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 B80.06	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR06.000.030	EUDAMEDFDA UDI	Class IIa	Active
EdgeEndo .06 Paper Points	SPP4506-1	EUDAMEDFDA UDI	Class IIa	Active
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper	PL-SEP-33E.0030	EUDAMED	Class IIa	Active
FQ Paper Points	PPFQ04.000.055	EUDAMED	Class IIa	Active
TotalFill® BC PointsTM Bioceramic Gutta Percha	5023119EU	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP49/8	EUDAMED	Class IIa	Active
Edge One R Gutta Percha Points	EORGP45-1	EUDAMEDFDA UDI	Class IIa	Active
Steriblue Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	SB-PP6TP025	EUDAMED	Class IIa	Active
Centra® Endo Gutta	SD4925	EUDAMED	Class IIa	Active
Septodont Gutta Percha	12844O	EUDAMED	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1435	EUDAMED	Class IIa	Active
Sure-Seal RootTM Bio GP Points	G912 CS60.02	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR04.000.050	EUDAMEDFDA UDI	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1440	EUDAMED	Class IIa	Active
Rachelendo Gutta Percha Points	G906 L45-80/.04	EUDAMED	Class IIa	Active
Sure-Cord Knitted Retraction Cord	SC-00	EUDAMEDFDA UDI	Class I	Active
Wellsamed Paper Points	WPP325 ISO25 Rot	EUDAMED	Class IIa	Active
Septodont Paper Points	12856A	EUDAMED	Class IIa	Active
Sure-Cord Knitted Retraction Cord	SC-000	EUDAMEDFDA UDI	Class I	Active
Procodile® Paper Points	PPPR05.000.040	EUDAMEDFDA UDI	Class IIa	Active
Guttapred Pointes de Gutta Percha	67109	EUDAMED	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