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S.S.K-Files

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref D-P.02.01-028-02-010-SR-000-00-00Model S.S.K-Files 28mm #10 6pcs/packRef CODE30K2125Model E30 S.S K Files 6s 21mm No.25Ref D-P.02.01-025-02-040-SR-000-00-00Model S.S.K-Files 25mm #40 6pcs/packRef CODE30K2170Model E30 S.S K Files 6s 21mm No.70Ref D-P.02.01-025-02-055-SR-000-00-00Model S.S.K-Files 25mm #55 6pcs/packRef D-P.02.01-021-02-050-SR-000-00-00Model S.S.K-Files 21mm #50 6pcs/packRef CODE30K211540Model E30 S.S K Files 6s 21mm No.15-40 Asst.Ref D-P.02.01-021-02-030-SR-000-00-00Model S.S.K-Files 21mm #30 6pcs/packRef D-P.02.01-028-02-008-SR-000-00-00Model S.S.K-Files 28mm #08 6pcs/packRef D-P.02.01-021-02-008-SR-000-00-00Model S.S.K-Files 21mm #08 6pcs/packRef D-P.02.01-021-02-025-SR-000-00-00Model S.S.K-Files 21mm #25 6pcs/packRef D-P.02.01-021-02-0A0-SR-000-00-00Model S.S.K-Files 21mm #15-40 6pcs/packRef D-P.02.01-021-02-055-SR-000-00-00Model S.S.K-Files 21mm #55 6pcs/packRef CODE30K2580Model E30 S.S K Files 6s 25mm No.80Ref D-P.02.01-025-02-050-SR-000-00-00Model S.S.K-Files 25mm #50 6pcs/packRef D-P.02.01-025-02-0A1-SR-000-00-00Model S.S.K-Files 25mm #45-80 6pcs/packRef CODE30K2115Model E30 S.S K Files 6s 21mm No.15Ref CODE30K2515Model E30 S.S K Files 6s 25mm No.15Ref CODE30K2550Model E30 S.S K Files 6s 25mm No.50Ref D-P.02.01-021-02-0A1-SR-000-00-00Model S.S.K-Files 21mm #45-80 6pcs/packRef CODE30K214580Model E30 S.S K Files 6s 21mm No.45-80 AsstRef CODE30K2130Model E30 S.S K Files 6s 21mm No.30Ref D-P.02.01-021-02-060-SR-000-00-00Model S.S.K-Files 21mm #60 6pcs/packRef CODE30K2535Model E30 S.S K Files 6s 25mm No.35Ref CODE30K254580Model E30 S.S K Files 6s 25mm No.45-80 Asst.Ref CODE30K2508Model E30 S.S K Files 6s 25mm No.08Ref D-P.02.01-021-02-070-SR-000-00-00Model S.S.K-Files 21mm #70 6pcs/packRef D-P.02.01-021-02-006-SR-000-00-00Model S.S.K-Files 21mm #06 6pcs/packRef CODE30K2135Model E30 S.S K Files 6s 21mm No.35Ref CODE30K2506Model E30 S.S K Files 6s 25mm No.06Ref CODE30K2525Model E30 S.S K Files 6s 25mm No.25Ref CODE30K251540Model E30 S.S K Files 6s 25mm No.15-40 Asst.Ref D-P.02.01-021-02-035-SR-000-00-00Model S.S.K-Files 21mm #35 6pcs/packRef D-P.02.01-021-02-045-SR-000-00-00Model S.S.K-Files 21mm #45 6pcs/packRef D-P.02.01-025-02-030-SR-000-00-00Model S.S.K-Files 25mm #30 6pcs/packRef D-P.02.01-021-02-080-SR-000-00-00Model S.S.K-Files 21mm #80 6pcs/packRef D-P.02.01-021-02-020-SR-000-00-00Model S.S.K-Files 21mm #20 6pcs/packRef D-P.02.01-031-02-040-SR-000-00-00Model S.S.K-Files 31mm #40 6pcs/packRef D-P.02.01-028-02-055-SR-000-00-00Model S.S.K-Files 28mm #55 6pcs/packRef D-P.02.01-028-02-025-SR-000-00-00Model S.S.K-Files 28mm #25 6pcs/packRef D-P.02.01-028-02-050-SR-000-00-00Model S.S.K-Files 28mm #50 6pcs/packRef D-P.02.01-031-02-010-SR-000-00-00Model S.S.K-Files 31mm #10 6pcs/packRef D-P.02.01-031-02-035-SR-000-00-00Model S.S.K-Files 31mm #35 6pcs/packRef D-P.02.01-031-02-070-SR-000-00-00Model S.S.K-Files 31mm #70 6pcs/packRef D-P.02.01-028-02-040-SR-000-00-00Model S.S.K-Files 28mm #40 6pcs/packRef D-P.02.01-031-02-015-SR-000-00-00Model S.S.K-Files 31mm #15 6pcs/packRef D-P.02.01-031-02-055-SR-000-00-00Model S.S.K-Files 31mm #55 6pcs/packRef D-P.02.01-028-02-035-SR-000-00-00Model S.S.K-Files 28mm #35 6pcs/packRef D-P.02.01-028-02-070-SR-000-00-00Model S.S.K-Files 28mm #70 6pcs/packRef D-P.02.01-031-02-020-SR-000-00-00Model S.S.K-Files 31mm #20 6pcs/packRef D-P.02.01-028-02-0A0-SR-000-00-00Model S.S.K-Files 28mm #15-40 6pcs/packRef D-P.02.01-031-02-050-SR-000-00-00Model S.S.K-Files 31mm #50 6pcs/packRef D-P.02.01-031-02-060-SR-000-00-00Model S.S.K-Files 31mm #60 6pcs/packRef D-P.02.01-031-02-0A1-SR-000-00-00Model S.S.K-Files 31mm #45-80 6pcs/packRef D-P.02.01-028-02-060-SR-000-00-00Model S.S.K-Files 28mm #60 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
S.S.K-Files EUDAMED
S.S K Files EUDAMED
Denco FDA UDI
Generic Name
Manual endodontic file/rasp, single-use FDA UDI
Device Name
S.S.K-Files EUDAMED
Dental Root Canal Instruments Reamers EUDAMED
D-P.02.01-031-02-015-SR-000-00-00 EUDAMED
Model / Reference
S.S.K-Files 28mm #10 6pcs/pack EUDAMED
D-P.02.01-028-02-010-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 21mm No.25 EUDAMED
CODE30K2125 EUDAMED
S.S.K-Files 25mm #40 6pcs/pack EUDAMED
D-P.02.01-025-02-040-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 21mm No.70 EUDAMED
CODE30K2170 EUDAMED
S.S.K-Files 25mm #55 6pcs/pack EUDAMED
D-P.02.01-025-02-055-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #50 6pcs/pack EUDAMED
D-P.02.01-021-02-050-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 21mm No.15-40 Asst. EUDAMED
CODE30K211540 EUDAMED
S.S.K-Files 21mm #30 6pcs/pack EUDAMED
D-P.02.01-021-02-030-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #08 6pcs/pack EUDAMED
D-P.02.01-028-02-008-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #08 6pcs/pack EUDAMED
D-P.02.01-021-02-008-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #25 6pcs/pack EUDAMED
D-P.02.01-021-02-025-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #15-40 6pcs/pack EUDAMED
D-P.02.01-021-02-0A0-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #55 6pcs/pack EUDAMED
D-P.02.01-021-02-055-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 25mm No.80 EUDAMED
CODE30K2580 EUDAMED
S.S.K-Files 25mm #50 6pcs/pack EUDAMED
D-P.02.01-025-02-050-SR-000-00-00 EUDAMED
S.S.K-Files 25mm #45-80 6pcs/pack EUDAMED
D-P.02.01-025-02-0A1-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 21mm No.15 EUDAMED
CODE30K2115 EUDAMED
E30 S.S K Files 6s 25mm No.15 EUDAMED
CODE30K2515 EUDAMED
E30 S.S K Files 6s 25mm No.50 EUDAMED
CODE30K2550 EUDAMED
S.S.K-Files 21mm #45-80 6pcs/pack EUDAMED
D-P.02.01-021-02-0A1-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 21mm No.45-80 Asst EUDAMED
CODE30K214580 EUDAMED
E30 S.S K Files 6s 21mm No.30 EUDAMED
CODE30K2130 EUDAMED
S.S.K-Files 21mm #60 6pcs/pack EUDAMED
D-P.02.01-021-02-060-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 25mm No.35 EUDAMED
CODE30K2535 EUDAMED
E30 S.S K Files 6s 25mm No.45-80 Asst. EUDAMED
CODE30K254580 EUDAMED
E30 S.S K Files 6s 25mm No.08 EUDAMED
CODE30K2508 EUDAMED
S.S.K-Files 21mm #70 6pcs/pack EUDAMED
D-P.02.01-021-02-070-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #06 6pcs/pack EUDAMED
D-P.02.01-021-02-006-SR-000-00-00 EUDAMED
E30 S.S K Files 6s 21mm No.35 EUDAMED
CODE30K2135 EUDAMED
E30 S.S K Files 6s 25mm No.06 EUDAMED
CODE30K2506 EUDAMED
E30 S.S K Files 6s 25mm No.25 EUDAMED
CODE30K2525 EUDAMED
E30 S.S K Files 6s 25mm No.15-40 Asst. EUDAMED
CODE30K251540 EUDAMED
S.S.K-Files 21mm #35 6pcs/pack EUDAMED
D-P.02.01-021-02-035-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #45 6pcs/pack EUDAMED
D-P.02.01-021-02-045-SR-000-00-00 EUDAMED
S.S.K-Files 25mm #30 6pcs/pack EUDAMED
D-P.02.01-025-02-030-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #80 6pcs/pack EUDAMED
D-P.02.01-021-02-080-SR-000-00-00 EUDAMED
S.S.K-Files 21mm #20 6pcs/pack EUDAMED
D-P.02.01-021-02-020-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #40 6pcs/pack EUDAMED
D-P.02.01-031-02-040-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #55 6pcs/pack EUDAMED
D-P.02.01-028-02-055-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #25 6pcs/pack EUDAMED
D-P.02.01-028-02-025-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #50 6pcs/pack EUDAMED
D-P.02.01-028-02-050-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #10 6pcs/pack EUDAMED
D-P.02.01-031-02-010-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #35 6pcs/pack EUDAMED
D-P.02.01-031-02-035-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #70 6pcs/pack EUDAMED
D-P.02.01-031-02-070-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #40 6pcs/pack EUDAMED
D-P.02.01-028-02-040-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #15 6pcs/pack EUDAMED
D-P.02.01-031-02-015-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #55 6pcs/pack EUDAMED
D-P.02.01-031-02-055-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #35 6pcs/pack EUDAMED
D-P.02.01-028-02-035-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #70 6pcs/pack EUDAMED
D-P.02.01-028-02-070-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #20 6pcs/pack EUDAMED
D-P.02.01-031-02-020-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #15-40 6pcs/pack EUDAMED
D-P.02.01-028-02-0A0-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #50 6pcs/pack EUDAMED
D-P.02.01-031-02-050-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #60 6pcs/pack EUDAMED
D-P.02.01-031-02-060-SR-000-00-00 EUDAMED
S.S.K-Files 31mm #45-80 6pcs/pack EUDAMED
D-P.02.01-031-02-0A1-SR-000-00-00 EUDAMED
S.S.K-Files 28mm #60 6pcs/pack EUDAMED
D-P.02.01-028-02-060-SR-000-00-00 EUDAMED
31mm Stainless Steel K-FILES (Hand Use) #35 FDA UDI
31mm Stainless Steel K-FILES (Hand Use) #20 FDA UDI
31mm Stainless Steel K-FILES (Hand Use) #15 FDA UDI
31mm Stainless Steel K-FILES (Hand Use) #10 FDA UDI

Identifiers

Primary DI / UDI-DI
06970514916446 EUDAMED
06942512504871 EUDAMED
06970514911069 EUDAMED
06942512504963 EUDAMED
06970514916200 EUDAMED
06970514916354 EUDAMED
06942512504857 EUDAMED
06970514916316 EUDAMED
06970514916439 EUDAMED
06970514916255 EUDAMED
06970514916309 EUDAMED
06970514916408 EUDAMED
06970514916361 EUDAMED
06942512505144 EUDAMED
06970514916194 EUDAMED
06970514916262 EUDAMED
06942512504840 EUDAMED
06942512505014 EUDAMED
06942512505106 EUDAMED
06970514916415 EUDAMED
06942512504925 EUDAMED
06942512504888 EUDAMED
06970514916378 EUDAMED
06942512505069 EUDAMED
06942512505090 EUDAMED
06942512504994 EUDAMED
06970514916385 EUDAMED
06970514916217 EUDAMED
06942512504895 EUDAMED
06942512504987 EUDAMED
06942512505045 EUDAMED
06942512505021 EUDAMED
06970514916323 EUDAMED
06970514916347 EUDAMED
06970514911045 EUDAMED
06970514916392 EUDAMED
06970514916293 EUDAMED
06970514916668 EUDAMEDFDA UDI
06970514916637 EUDAMEDFDA UDI
06970514916620 EUDAMEDFDA UDI
06970514916613 EUDAMEDFDA UDI
06970514916675 EUDAMED
06970514916538 EUDAMED
06970514916477 EUDAMED
06970514916521 EUDAMED
06970514916729 EUDAMED
06970514916507 EUDAMED
06970514916705 EUDAMED
06970514916491 EUDAMED
06970514916552 EUDAMED
06970514916576 EUDAMED
06970514916699 EUDAMED
06970514916712 EUDAMED
06970514916750 EUDAMED
06970514916545 EUDAMED
Basic UDI-DI
B-06970514916446 EUDAMED
B-06942512504871 EUDAMED
B-06970514911069 EUDAMED
B-06942512504963 EUDAMED
B-06970514916200 EUDAMED
B-06970514916354 EUDAMED
B-06942512504857 EUDAMED
B-06970514916316 EUDAMED
B-06970514916439 EUDAMED
B-06970514916255 EUDAMED
B-06970514916309 EUDAMED
B-06970514916408 EUDAMED
B-06970514916361 EUDAMED
B-06942512505144 EUDAMED
B-06970514916194 EUDAMED
B-06970514916262 EUDAMED
B-06942512504840 EUDAMED
B-06942512505014 EUDAMED
B-06942512505106 EUDAMED
B-06970514916415 EUDAMED
B-06942512504925 EUDAMED
B-06942512504888 EUDAMED
B-06970514916378 EUDAMED
B-06942512505069 EUDAMED
B-06942512505090 EUDAMED
B-06942512504994 EUDAMED
B-06970514916385 EUDAMED
B-06970514916217 EUDAMED
B-06942512504895 EUDAMED
B-06942512504987 EUDAMED
B-06942512505045 EUDAMED
B-06942512505021 EUDAMED
B-06970514916323 EUDAMED
B-06970514916347 EUDAMED
B-06970514911045 EUDAMED
B-06970514916392 EUDAMED
B-06970514916293 EUDAMED
B-06970514916675 EUDAMED
B-06970514916538 EUDAMED
B-06970514916477 EUDAMED
B-06970514916521 EUDAMED
B-06970514916613 EUDAMED
B-06970514916668 EUDAMED
B-06970514916729 EUDAMED
B-06970514916507 EUDAMED
B-06970514916620 EUDAMED
B-06970514916705 EUDAMED
B-06970514916491 EUDAMED
B-06970514916552 EUDAMED
B-06970514916637 EUDAMED
B-06970514916576 EUDAMED
B-06970514916699 EUDAMED
B-06970514916712 EUDAMED
B-06970514916750 EUDAMED
B-06970514916545 EUDAMED
FDA Product Code
EKS FDA UDI
EMDN Code
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
GMDN Term
Manual 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
Türkiye EUDAMED
Poland 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

S.S.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 (59)

  • EUDAMED 8b67d36a-8248-4dc8-8829-cad62219cbba 61 fields · synced Sep 18, 2026
  • EUDAMED 4057da7d-83fc-4960-a849-ff2fcb931b2c 61 fields · synced May 16, 2026
  • EUDAMED 24919124-4767-4862-9f35-ddd27b94bd00 61 fields · synced May 16, 2026
  • EUDAMED da853ba8-fa07-462d-ad23-82430efbaf8e 61 fields · synced May 16, 2026
  • EUDAMED cdb03ccc-0d66-489b-821b-d83af027bc7d 61 fields · synced May 16, 2026
  • EUDAMED 603506f4-7472-47c3-9265-1e5916949d46 61 fields · synced May 17, 2026
  • EUDAMED 4b11e784-bf92-40a1-8702-a8d7b2f3c5ef 61 fields · synced May 17, 2026
  • EUDAMED f5469678-8c01-447e-9434-62cf94223cc6 61 fields · synced May 17, 2026
  • EUDAMED 21013be5-155f-4310-afd7-e73d7530d389 61 fields · synced May 17, 2026
  • EUDAMED 1c57f5c7-98c0-4633-a356-b123064d7a03 61 fields · synced May 17, 2026
  • EUDAMED 707e243d-ca60-467d-a836-870e027ce09d 61 fields · synced May 17, 2026
  • EUDAMED 29255acb-d276-401b-9aae-950c2c2cfa49 61 fields · synced May 17, 2026
  • EUDAMED 7f36080e-9ca1-4bf6-904a-7c60bf3981fc 61 fields · synced May 17, 2026
  • EUDAMED 1be510a8-cefc-46d6-9838-1957b6ec444f 61 fields · synced May 17, 2026
  • EUDAMED 2c07c91d-ff05-4e19-b1d2-d837e08f3fc3 61 fields · synced May 17, 2026
  • EUDAMED 37c9f570-b99b-4171-9c29-d55be381da79 61 fields · synced May 17, 2026
  • EUDAMED 6b82f379-0ad5-44cc-945b-45e2f7dc5bb7 61 fields · synced May 17, 2026
  • EUDAMED 9608f42c-5ab5-4156-ac0c-c8501afbeee8 61 fields · synced May 17, 2026
  • EUDAMED f76d2546-525d-4010-a681-f53d9e99f038 61 fields · synced May 18, 2026
  • EUDAMED 7be3a60c-79e7-4226-b684-e3a18cd1468c 61 fields · synced May 18, 2026
  • EUDAMED dcf5a1af-97d5-4650-8d19-452baf40e7b2 61 fields · synced May 18, 2026
  • EUDAMED f8bd3fa6-41ca-4e9a-89ec-5123b196192c 61 fields · synced May 18, 2026
  • EUDAMED 86cdcfc3-0ae0-47c2-9769-e9e467384446 61 fields · synced May 18, 2026
  • EUDAMED 9e0ee024-2913-42b3-beef-8d6d6d0035e6 61 fields · synced May 18, 2026
  • EUDAMED 0cfe36eb-1a82-45d7-a159-a85aa9f94d9b 61 fields · synced May 18, 2026
  • EUDAMED a7674cd9-f26f-412a-b2ba-922b266d8695 61 fields · synced May 18, 2026
  • EUDAMED 9ba27750-ed4b-4102-b377-be216f9a36ae 61 fields · synced May 18, 2026
  • EUDAMED 2a3b5896-e3d3-4c0d-aaaa-1ca1aa773f84 61 fields · synced May 18, 2026
  • EUDAMED 91cda3d3-77ed-4c95-b446-4c897a1e3216 61 fields · synced May 18, 2026
  • EUDAMED 1b952508-37b4-4553-ad17-d1e6970f5ab6 61 fields · synced May 18, 2026
  • EUDAMED 89a82a72-f48e-4a9e-a835-608bf6562f4c 61 fields · synced May 18, 2026
  • EUDAMED 24857a7b-8053-4336-b33b-e7b87e1e20b2 61 fields · synced May 19, 2026
  • EUDAMED 0a012e8f-1a00-4fbd-9aa7-ae5bae4c7930 61 fields · synced May 19, 2026
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