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SHENZHEN DENCO MEDICAL CO., LTD.

China·CN-MF-000014271

Last updated September 17, 2026

Information

Country: China
Address: Room 3108, Block 6, Tian'an Cloud Park , Bantian street, Longgang District, Shenzhen, 518129，Guangdong P.R.China, Shenzhen, China
Website: www.dencodent.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 755 23764065
PRRC Contact: Nature Xu
EUDAMED SRN: CN-MF-000014271
FDA FEI Number: 3011554142
DUNS Number: —

Catalogue (1490)

Page 4 of 30

Device	Model / Reference	Registries	Class	Status
NITI Spreaders	D-P.03.04-028-02-020-SR-000-00-00	EUDAMED	Class IIa	Active
S.S Reamers	D-P.02.03-028-02-030-SR-000-00-00	EUDAMED	Class IIa	Active
Super files	D-P.01.01-031-05-0F5-RB-000-00-00	EUDAMED	Class IIa	Active
S.S Spreaders	D-P.02.04-025-02-008-SR-000-00-00	EUDAMED	Class IIa	Active
NITI K-Files	D-P.03.01-028-02-050-SR-000-00-00	EUDAMED	Class IIa	Active
NITI H-Files	D-P.03.02-025-02-015-SR-000-00-00	EUDAMED	Class IIa	Active
NITI Reamers	D-P.03.03-025-02-0A1-SR-000-00-00	EUDAMED	Class IIa	Active
NITI Reamers	D-P.03.03-028-02-0A0-SR-000-00-00	EUDAMED	Class IIa	Active
GC-Files	D-P.04.07-025-02-025-SR-000-00-00	EUDAMED	Class IIa	Active
NITI Reamers	D-P.03.03-028-02-055-SR-000-00-00	EUDAMED	Class IIa	Active
Super files	D-P.01.01-031-09-0F3-RB-000-00-00	EUDAMED	Class IIa	Active
S.S.K-Files	D-P.02.01-031-02-080-SR-000-00-00	EUDAMED	Class IIa	Active
NITI Reamers	D-P.03.03-025-02-010-SR-000-00-00	EUDAMED	Class IIa	Active
NITI H-Files	D-P.03.02-028-02-025-SR-000-00-00	EUDAMED	Class IIa	Active
NITI H-Files	D-P.03.02-021-02-0A1-SR-000-00-00	EUDAMED	Class IIa	Active
NITI K-Files	D-P.03.01-031-02-035-SR-000-00-00	EUDAMED	Class IIa	Active
Super files	D-P.01.01-031-07-0F1-RB-000-00-00	EUDAMED	Class IIa	Active
NITI K-Files	D-P.03.01-031-02-015-SR-000-00-00	EUDAMED	Class IIa	Active
Denco	Micro Scope K Files #15-40	FDA UDI	Class I	Unknown
Avalon Biomed	BlueShaper sterile files 31mm Z7 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	Excalibur sterile 25mm E35 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	ApicalShaper sterile 21mm Z30-Z50 (4 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper sterile files 25mm Z2 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper PRO sterile files 31mm Z1 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	SlimShaper PRO sterile files 31mm ZS1-ZS3 (3 units)	FDA UDI	Class I	Active
Avalon Biomed	ApicalShaper sterile 21mm Z50/03 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	NanoShaper Assorted 31 ZN1-ZN3 (3 units)	FDA UDI	Class I	Active
Avalon Biomed	SlimShaper sterile files 21mm ZS2 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	SlimShaper PRO sterile files 21mm ZS1-ZS3 (3 units)	FDA UDI	Class I	Active
Avalon Biomed	Z-Glider sterile files 31mm (3units)	FDA UDI	Class I	Active
Avalon Biomed	NanoShaper 21 ZN1 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper sterile files 31mm Z1 (6 units)	FDA UDI	Class I	Active
Denco	31mm Stainless Steel K-FILES (Hand Use) #08	EUDAMEDFDA UDI	Class I	Active
Avalon Biomed	BlueShaper PRO sterile files 25mm Z1-Z4 (4 units)	FDA UDI	Class I	Active
Avalon Biomed	NanoShaper Assorted 21 ZN1-ZN3 (3 units)	FDA UDI	Class I	Active
Avalon Biomed	SlimShaper sterile files 25mm ZS1 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper sterile files 21mm Z4 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper PRO sterile files 31mm Z7 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper PRO sterile files 25mm Z6 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	Excalibur PRO sterile 31mm E35 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper PRO sterile 21mm ZXS-Z5	FDA UDI	Class I	Active
Zarc	NanoShaper 21 ZN2 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper PRO sterile files 21mm Z4 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	NanoShaper 31 ZN3 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	Z-Gauge Ruler	FDA UDI	Class I	Active
Avalon Biomed	Yellow File Organizer and autoclavable ruler Zarc	FDA UDI	Class I	Active
Avalon Biomed	NanoShaper Assorted 25 ZN1-ZN3 (3 units)	FDA UDI	Class I	Active
Avalon Biomed	BlueShaper sterile files 25mm Z1 (6 units)	FDA UDI	Class I	Active
Avalon Biomed	SlimShaper PRO sterile files 25mm ZS3 (6 units)	FDA UDI	Class I	Active
Denco	21mm Niti K file(For hand) #70	EUDAMEDFDA UDI	Class I	Active

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