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NiTi K Files

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref CODE32K25NT15Model E32 NiTi K Files 6s 25mm No.15Ref CODE32K25NT4580Model E32 NiTi K Files 6s 25mm No.45-80 Asst.Ref CODE32K21NT10Model E32 NiTi K Files 6s 21mm No.10Ref CODE32K25NT10Model E32 NiTi K Files 6s 25mm No.10Ref CODE32K21NT60Model E32 NiTi K Files 6s 21mm No.60Ref CODE32K25NT40Model E32 NiTi K Files 6s 25mm No.40Ref CODE32K25NT1540Model E32 NiTi K Files 6s 25mm No.15-40 Asst.Ref CODE32K21NT40Model E32 NiTi K Files 6s 21mm No.40Ref CODE32K21NT4580Model E32 NiTi K Files 6s 21mm No.45-80 Asst.Ref CODE32K21NT15Model E32 NiTi K Files 6s 21mm No.15Ref CODE32K21NT50Model E32 NiTi K Files 6s 21mm No.50Ref CODE32K25NT45Model E32 NiTi K Files 6s 25mm No.45Ref CODE32K25NT70Model E32 NiTi K Files 6s 25mm No.70Ref CODE32K25NT30Model E32 NiTi K Files 6s 25mm No.30Ref CODE32K21NT25Model E32 NiTi K Files 6s 21mm No.25Ref CODE32K25NT35Model E32 NiTi K Files 6s 25mm No.35Ref CODE32K25NT50Model E32 NiTi K Files 6s 25mm No.50Ref CODE32K21NT1540Model E32 NiTi K Files 6s 21mm No.15-40 Asst.Ref D-P.03.01-025-02-035-SR-000-00-00Model NITI K-Files 25mm #35 6pcs/packRef D-P.03.01-025-02-080-SR-000-00-00Model NITI K-Files 25mm #80 6pcs/packRef D-P.03.01-028-02-006-SR-000-00-00Model NITI K-Files 28mm #06 6pcs/packRef D-P.03.01-028-02-035-SR-000-00-00Model NITI K-Files 28mm #35 6pcs/packRef D-P.03.01-028-02-010-SR-000-00-00Model NITI K-Files 28mm #10 6pcs/packRef D-P.03.01-025-02-008-SR-000-00-00Model NITI K-Files 25mm #08 6pcs/packRef D-P.03.01-021-02-006-SR-000-00-00Model NITI K-Files 21mm #06 6pcs/packRef D-P.03.01-025-02-055-SR-000-00-00Model NITI K-Files 25mm #55 6pcs/packRef D-P.03.01-031-02-006-SR-000-00-00Model NITI K-Files 31mm #06 6pcs/packRef D-P.03.01-025-02-020-SR-000-00-00Model NITI K-Files 25mm #20 6pcs/packRef D-P.03.01-025-02-070-SR-000-00-00Model NITI K-Files 25mm #70 6pcs/packRef D-P.03.01-021-02-080-SR-000-00-00Model NITI K-Files 21mm #80 6pcs/packRef D-P.03.01-031-02-025-SR-000-00-00Model NITI K-Files 31mm #25 6pcs/packRef D-P.03.01-028-02-015-SR-000-00-00Model NITI K-Files 28mm #15 6pcs/packRef D-P.03.01-031-02-020-SR-000-00-00Model NITI K-Files 31mm #20 6pcs/packRef D-P.03.01-025-02-045-SR-000-00-00Model NITI K-Files 25mm #45 6pcs/packRef D-P.03.01-031-02-040-SR-000-00-00Model NITI K-Files 31mm #40 6pcs/packRef D-P.03.01-028-02-045-SR-000-00-00Model NITI K-Files 28mm #45 6pcs/packRef D-P.03.01-021-02-040-SR-000-00-00Model NITI K-Files 21mm #40 6pcs/packRef D-P.03.01-025-02-025-SR-000-00-00Model NITI K-Files 25mm #25 6pcs/packRef D-P.03.01-025-02-030-SR-000-00-00Model NITI K-Files 25mm #30 6pcs/packRef D-P.03.01-031-02-045-SR-000-00-00Model NITI K-Files 31mm #45 6pcs/packRef D-P.03.01-021-02-0A0-SR-000-00-00Model NITI K-Files 21mm #15-40 6pcs/packRef D-P.03.01-021-02-055-SR-000-00-00Model NITI K-Files 21mm #55 6pcs/packRef D-P.03.01-021-02-025-SR-000-00-00Model NITI K-Files 21mm #25 6pcs/packRef D-P.03.01-021-02-035-SR-000-00-00Model NITI K-Files 21mm #35 6pcs/packRef D-P.03.01-028-02-020-SR-000-00-00Model NITI K-Files 28mm #20 6pcs/packRef D-P.03.01-021-02-010-SR-000-00-00Model NITI K-Files 21mm #10 6pcs/packRef D-P.03.01-028-02-0A0-SR-000-00-00Model NITI K-Files 28mm #15-40 6pcs/packRef D-P.03.01-028-02-080-SR-000-00-00Model NITI K-Files 28mm #80 6pcs/packRef D-P.03.01-025-02-015-SR-000-00-00Model NITI K-Files 25mm #15 6pcs/packRef D-P.03.01-031-02-0A0-SR-000-00-00Model NITI K-Files 31mm #15-40 6pcs/packRef D-P.03.01-028-02-070-SR-000-00-00Model NITI K-Files 28mm #70 6pcs/packRef D-P.03.01-021-02-060-SR-000-00-00Model NITI K-Files 21mm #60 6pcs/packRef D-P.03.01-031-02-030-SR-000-00-00Model NITI K-Files 31mm #30 6pcs/packRef DD60147804001Model NITI K-Files 21mm #15 6pcs/packRef D-P.03.01-028-02-040-SR-000-00-00Model NITI K-Files 28mm #40 6pcs/packRef D-P.03.01-028-02-008-SR-000-00-00Model NITI K-Files 28mm #08 6pcs/packRef D-P.03.01-021-02-030-SR-000-00-00Model NITI K-Files 21mm #30 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
NiTi K Files EUDAMED
NITI K-Files EUDAMED
Denco FDA UDI
Generic Name
Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Device Name
Dental Root Canal Instruments Files EUDAMED
NITI K-Files EUDAMED
Model / Reference
E32 NiTi K Files 6s 25mm No.15 EUDAMED
CODE32K25NT15 EUDAMED
E32 NiTi K Files 6s 25mm No.45-80 Asst. EUDAMED
CODE32K25NT4580 EUDAMED
E32 NiTi K Files 6s 21mm No.10 EUDAMED
CODE32K21NT10 EUDAMED
E32 NiTi K Files 6s 25mm No.10 EUDAMED
CODE32K25NT10 EUDAMED
E32 NiTi K Files 6s 21mm No.60 EUDAMED
CODE32K21NT60 EUDAMED
E32 NiTi K Files 6s 25mm No.40 EUDAMED
CODE32K25NT40 EUDAMED
E32 NiTi K Files 6s 25mm No.15-40 Asst. EUDAMED
CODE32K25NT1540 EUDAMED
E32 NiTi K Files 6s 21mm No.40 EUDAMED
CODE32K21NT40 EUDAMED
E32 NiTi K Files 6s 21mm No.45-80 Asst. EUDAMED
CODE32K21NT4580 EUDAMED
E32 NiTi K Files 6s 21mm No.15 EUDAMED
CODE32K21NT15 EUDAMED
E32 NiTi K Files 6s 21mm No.50 EUDAMED
CODE32K21NT50 EUDAMED
E32 NiTi K Files 6s 25mm No.45 EUDAMED
CODE32K25NT45 EUDAMED
E32 NiTi K Files 6s 25mm No.70 EUDAMED
CODE32K25NT70 EUDAMED
E32 NiTi K Files 6s 25mm No.30 EUDAMED
CODE32K25NT30 EUDAMED
E32 NiTi K Files 6s 21mm No.25 EUDAMED
CODE32K21NT25 EUDAMED
E32 NiTi K Files 6s 25mm No.35 EUDAMED
CODE32K25NT35 EUDAMED
E32 NiTi K Files 6s 25mm No.50 EUDAMED
CODE32K25NT50 EUDAMED
E32 NiTi K Files 6s 21mm No.15-40 Asst. EUDAMED
CODE32K21NT1540 EUDAMED
NITI K-Files 25mm #35 6pcs/pack EUDAMED
D-P.03.01-025-02-035-SR-000-00-00 EUDAMED
NITI K-Files 25mm #80 6pcs/pack EUDAMED
D-P.03.01-025-02-080-SR-000-00-00 EUDAMED
NITI K-Files 28mm #06 6pcs/pack EUDAMED
D-P.03.01-028-02-006-SR-000-00-00 EUDAMED
NITI K-Files 28mm #35 6pcs/pack EUDAMED
D-P.03.01-028-02-035-SR-000-00-00 EUDAMED
NITI K-Files 28mm #10 6pcs/pack EUDAMED
D-P.03.01-028-02-010-SR-000-00-00 EUDAMED
NITI K-Files 25mm #08 6pcs/pack EUDAMED
D-P.03.01-025-02-008-SR-000-00-00 EUDAMED
NITI K-Files 21mm #06 6pcs/pack EUDAMED
D-P.03.01-021-02-006-SR-000-00-00 EUDAMED
NITI K-Files 25mm #55 6pcs/pack EUDAMED
D-P.03.01-025-02-055-SR-000-00-00 EUDAMED
NITI K-Files 31mm #06 6pcs/pack EUDAMED
D-P.03.01-031-02-006-SR-000-00-00 EUDAMED
NITI K-Files 25mm #20 6pcs/pack EUDAMED
D-P.03.01-025-02-020-SR-000-00-00 EUDAMED
NITI K-Files 25mm #70 6pcs/pack EUDAMED
D-P.03.01-025-02-070-SR-000-00-00 EUDAMED
NITI K-Files 21mm #80 6pcs/pack EUDAMED
D-P.03.01-021-02-080-SR-000-00-00 EUDAMED
NITI K-Files 31mm #25 6pcs/pack EUDAMED
D-P.03.01-031-02-025-SR-000-00-00 EUDAMED
NITI K-Files 28mm #15 6pcs/pack EUDAMED
D-P.03.01-028-02-015-SR-000-00-00 EUDAMED
NITI K-Files 31mm #20 6pcs/pack EUDAMED
D-P.03.01-031-02-020-SR-000-00-00 EUDAMED
NITI K-Files 25mm #45 6pcs/pack EUDAMED
D-P.03.01-025-02-045-SR-000-00-00 EUDAMED
NITI K-Files 31mm #40 6pcs/pack EUDAMED
D-P.03.01-031-02-040-SR-000-00-00 EUDAMED
NITI K-Files 28mm #45 6pcs/pack EUDAMED
D-P.03.01-028-02-045-SR-000-00-00 EUDAMED
NITI K-Files 21mm #40 6pcs/pack EUDAMED
D-P.03.01-021-02-040-SR-000-00-00 EUDAMED
NITI K-Files 25mm #25 6pcs/pack EUDAMED
D-P.03.01-025-02-025-SR-000-00-00 EUDAMED
NITI K-Files 25mm #30 6pcs/pack EUDAMED
D-P.03.01-025-02-030-SR-000-00-00 EUDAMED
NITI K-Files 31mm #45 6pcs/pack EUDAMED
D-P.03.01-031-02-045-SR-000-00-00 EUDAMED
NITI K-Files 21mm #15-40 6pcs/pack EUDAMED
D-P.03.01-021-02-0A0-SR-000-00-00 EUDAMED
NITI K-Files 21mm #55 6pcs/pack EUDAMED
D-P.03.01-021-02-055-SR-000-00-00 EUDAMED
NITI K-Files 21mm #25 6pcs/pack EUDAMED
D-P.03.01-021-02-025-SR-000-00-00 EUDAMED
NITI K-Files 21mm #35 6pcs/pack EUDAMED
D-P.03.01-021-02-035-SR-000-00-00 EUDAMED
NITI K-Files 28mm #20 6pcs/pack EUDAMED
D-P.03.01-028-02-020-SR-000-00-00 EUDAMED
NITI K-Files 21mm #10 6pcs/pack EUDAMED
D-P.03.01-021-02-010-SR-000-00-00 EUDAMED
NITI K-Files 28mm #15-40 6pcs/pack EUDAMED
D-P.03.01-028-02-0A0-SR-000-00-00 EUDAMED
NITI K-Files 28mm #80 6pcs/pack EUDAMED
D-P.03.01-028-02-080-SR-000-00-00 EUDAMED
NITI K-Files 25mm #15 6pcs/pack EUDAMED
D-P.03.01-025-02-015-SR-000-00-00 EUDAMED
NITI K-Files 31mm #15-40 6pcs/pack EUDAMED
D-P.03.01-031-02-0A0-SR-000-00-00 EUDAMED
NITI K-Files 28mm #70 6pcs/pack EUDAMED
D-P.03.01-028-02-070-SR-000-00-00 EUDAMED
NITI K-Files 21mm #60 6pcs/pack EUDAMED
D-P.03.01-021-02-060-SR-000-00-00 EUDAMED
NITI K-Files 31mm #30 6pcs/pack EUDAMED
D-P.03.01-031-02-030-SR-000-00-00 EUDAMED
NITI K-Files 21mm #15 6pcs/pack EUDAMED
DD60147804001 EUDAMED
NITI K-Files 28mm #40 6pcs/pack EUDAMED
D-P.03.01-028-02-040-SR-000-00-00 EUDAMED
NITI K-Files 28mm #08 6pcs/pack EUDAMED
D-P.03.01-028-02-008-SR-000-00-00 EUDAMED
NITI K-Files 21mm #30 6pcs/pack EUDAMED
D-P.03.01-021-02-030-SR-000-00-00 EUDAMED
21mm Niti K file(For hand) #35 FDA UDI

Identifiers

Primary DI / UDI-DI
06942512505311 EUDAMED
06942512505397 EUDAMED
06942512505151 EUDAMED
06942512505304 EUDAMED
06942512505274 EUDAMED
06942512505373 EUDAMED
06942512505328 EUDAMED
06942512505229 EUDAMED
06942512505243 EUDAMED
06942512505168 EUDAMED
06942512505250 EUDAMED
06942512505380 EUDAMED
06942512505434 EUDAMED
06942512505359 EUDAMED
06942512505199 EUDAMED
06942512505366 EUDAMED
06942512505403 EUDAMED
06942512505175 EUDAMED
06970514914244 EUDAMEDFDA UDI
06970514910369 EUDAMED
06970514914404 EUDAMED
06970514914428 EUDAMED
06970514910444 EUDAMED
06970514910390 EUDAMED
06970514910307 EUDAMED
06970514910956 EUDAMED
06970514914374 EUDAMED
06970514914510 EUDAMED
06970514910338 EUDAMED
06970514914398 EUDAMED
06970514914312 EUDAMED
06970514914572 EUDAMED
06970514910406 EUDAMED
06970514910475 EUDAMED
06970514914350 EUDAMED
06970514914602 EUDAMED
06970514914442 EUDAMED
06970514914251 EUDAMED
06970514910345 EUDAMED
06970514910352 EUDAMED
06970514914619 EUDAMED
06970514914329 EUDAMED
06970514914282 EUDAMED
06970514914220 EUDAMED
06970514910413 EUDAMED
06970514910932 EUDAMED
06970514910451 EUDAMED
06970514914497 EUDAMED
06970514910321 EUDAMED
06970514914671 EUDAMED
06970514914480 EUDAMED
06970514914299 EUDAMED
06970514914589 EUDAMED
06970514910925 EUDAMED
06970514914435 EUDAMED
06970514910383 EUDAMED
06970514914237 EUDAMED
Basic UDI-DI
B-06942512505311 EUDAMED
B-06942512505397 EUDAMED
B-06942512505151 EUDAMED
B-06942512505304 EUDAMED
B-06942512505274 EUDAMED
B-06942512505373 EUDAMED
B-06942512505328 EUDAMED
B-06942512505229 EUDAMED
B-06942512505243 EUDAMED
B-06942512505168 EUDAMED
B-06942512505250 EUDAMED
B-06942512505380 EUDAMED
B-06942512505434 EUDAMED
B-06942512505359 EUDAMED
B-06942512505199 EUDAMED
B-06942512505366 EUDAMED
B-06942512505403 EUDAMED
B-06942512505175 EUDAMED
B-06970514910369 EUDAMED
B-06970514914404 EUDAMED
B-06970514914428 EUDAMED
B-06970514910444 EUDAMED
B-06970514910390 EUDAMED
B-06970514910307 EUDAMED
B-06970514910956 EUDAMED
B-06970514914374 EUDAMED
B-06970514914510 EUDAMED
B-06970514910338 EUDAMED
B-06970514914398 EUDAMED
B-06970514914312 EUDAMED
B-06970514914572 EUDAMED
B-06970514910406 EUDAMED
B-06970514910475 EUDAMED
B-06970514914350 EUDAMED
B-06970514914602 EUDAMED
B-06970514914442 EUDAMED
B-06970514914251 EUDAMED
B-06970514910345 EUDAMED
B-06970514910352 EUDAMED
B-06970514914619 EUDAMED
B-06970514914329 EUDAMED
B-06970514914282 EUDAMED
B-06970514914220 EUDAMED
B-06970514914244 EUDAMED
B-06970514910413 EUDAMED
B-06970514910932 EUDAMED
B-06970514910451 EUDAMED
B-06970514914497 EUDAMED
B-06970514910321 EUDAMED
B-06970514914671 EUDAMED
B-06970514914480 EUDAMED
B-06970514914299 EUDAMED
B-06970514914589 EUDAMED
B-06970514910925 EUDAMED
B-06970514914435 EUDAMED
B-06970514910383 EUDAMED
B-06970514914237 EUDAMED
FDA Product Code
EKS FDA UDI
EMDN Code
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Market of Registration
Poland EUDAMED
Türkiye EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

NiTi K Files by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Denco Medical Co., Ltd.
EUDAMED SRN
CN-MF-000014271
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (58)

  • EUDAMED 8c17dbd8-b17d-4943-96b4-3c5fd1f4e12c 61 fields · synced Sep 18, 2026
  • EUDAMED b289977f-802b-4942-ab93-f5ccd1503b7e 61 fields · synced May 11, 2026
  • EUDAMED 89c66829-d2ce-49e0-8e00-407c4da25b5a 61 fields · synced May 16, 2026
  • EUDAMED 2f8fad87-ec3e-49ca-a52d-4cde3e3a42cf 61 fields · synced May 16, 2026
  • EUDAMED 3a55d1ff-2e3b-416f-a2f8-9bdaf9501a08 61 fields · synced May 17, 2026
  • EUDAMED 202cdeaf-1925-472d-b7d7-8cfd8da2c6e9 61 fields · synced May 17, 2026
  • EUDAMED 993f740e-3b44-4fef-887b-31d3ae604dd4 61 fields · synced May 17, 2026
  • EUDAMED 2eab9968-9e67-4900-8ca5-6a555a856b31 61 fields · synced May 17, 2026
  • EUDAMED b84a7079-55a7-4a62-8720-ea0d1473f589 61 fields · synced May 17, 2026
  • EUDAMED bfa38561-bca7-4d8e-bcf4-b3e8a2e0043b 61 fields · synced May 17, 2026
  • EUDAMED 4cad6cfa-1b2a-4415-8e77-0cd5e0bc7ef6 61 fields · synced May 18, 2026
  • EUDAMED 06ecd6d2-6080-4717-bb34-05bb64fb160f 61 fields · synced May 18, 2026
  • EUDAMED ba71e024-64c5-4daf-a774-91677e79add7 61 fields · synced May 18, 2026
  • EUDAMED 6decabc8-8ad8-4cc2-85ad-dc54b2b7d851 61 fields · synced May 18, 2026
  • EUDAMED 8c179646-237d-41dc-945a-d56f163c46d9 61 fields · synced May 18, 2026
  • EUDAMED 59e5cbcf-690a-438f-87a8-90f65e00bf87 61 fields · synced May 18, 2026
  • EUDAMED 60ea65c3-0aa8-4514-a7d4-d1e93a325f09 61 fields · synced May 18, 2026
  • EUDAMED 9f2ff2f2-aed8-46c3-b0d8-9afedd064d5a 61 fields · synced May 19, 2026
  • FDA UDI b9f70bef-2ecf-45f0-ac58-b0c720b8eee5 33 fields · synced May 29, 2026
  • EUDAMED 42a1cb04-02ca-4550-a22a-778bea944715 61 fields · synced Jun 18, 2026
  • EUDAMED 8515ebf6-15f6-4145-acd5-4b84994d9af2 61 fields · synced Jun 20, 2026
  • EUDAMED 3e98ce2f-32fa-4c74-a0f0-3dd94bb59610 61 fields · synced Jul 9, 2026
  • EUDAMED 05e17580-b2b4-4312-9515-d34abffe677b 61 fields · synced Jul 9, 2026
  • EUDAMED b03dc1c4-f937-4324-b0bc-03acbc32df4c 61 fields · synced Jul 9, 2026
  • EUDAMED 40da1311-2d54-4462-aeeb-c695668ffb19 61 fields · synced Jul 9, 2026
  • EUDAMED 66cca605-aee3-46c8-a8ee-ea0b32fb66ce 61 fields · synced Jul 10, 2026
  • EUDAMED 2dba5ff1-b214-434c-94e7-05b460e61ac2 61 fields · synced Jul 11, 2026
  • EUDAMED f2e0e910-3866-4330-8388-8a66fd22b01c 61 fields · synced Jul 11, 2026
  • EUDAMED 5d213e36-5089-4fa0-9098-f81edc545e74 61 fields · synced Jul 12, 2026
  • EUDAMED 5539b7ee-eac4-4a0d-a320-cd979443446d 61 fields · synced Jul 12, 2026
  • EUDAMED b8d56e13-f3bc-42cd-9b34-eac6d55fe774 61 fields · synced Jul 12, 2026
  • EUDAMED 07385a27-94c0-400d-9652-ff937bb601e6 61 fields · synced Jul 13, 2026
  • EUDAMED 16bd6152-2b4c-4e97-bb92-b0d5f22c8ddd 61 fields · synced Jul 14, 2026
  • EUDAMED 1a83bfe2-ce6e-4563-9908-73a1c1d53abf 61 fields · synced Jul 14, 2026
  • EUDAMED 7305faae-62df-409d-be51-1d610c2e3a2b 61 fields · synced Jul 14, 2026
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