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Super Files

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref D-P.03.07-025-VT-0A0-SR-000-00-00Model Super Files For Hand Use 25mm SX-F3 6pcs/packRef D-P.03.07-021-08-0F2-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 21mm F2 6pcs/packRef D-P.01.01-025-09-0F3-SR-000-00-00Model Super Files 25mm F3 6pcs/packRef D-P.03.07-025-08-0F2-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm F2 6pcs/packRef D-P.03.07-021-VT-0A0-SR-000-00-00Model Super Files For Hand Use 21mm SX-F3 6pcs/packRef D-P.03.07-025-08-0F2-SR-000-00-00Model Super Files For Hand Use 25mm F2 6pcs/packRef D-P.03.07-021-06-0F4-SR-000-00-00Model Super Files For Hand Use 21mm F4 6pcs/packRef D-P.01.01-031-VT-0S1-SR-000-00-00Model Super Files 31mm S1 6pcs/packRef D-P.01.01-021-VT-0A0-SR-000-00-00Model Super Files 21mm SX-F3 6pcs/packRef D-P.03.07-031-05-0F5-SR-000-00-00Model Super Files For Hand Use 31mm F5 6pcs/packRef D-P.03.07-019-VT-0SX-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 19mm SX 6pcs/packRef D-P.01.01-021-08-0F2-SR-000-00-00Model Super Files 21mm F2 6pcs/packRef D-P.03.07-025-06-0F4-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm F4 6pcs/packRef D-P.01.01-031-07-0F1-SR-000-00-00Model Super Files 31mm F1 6pcs/packRef D-P.01.01-025-06-0F4-SR-000-00-00Model Super Files 25mm F4 6pcs/packRef D-P.03.07-021-09-0F3-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 21mm F3 6pcs/packRef D-P.01.01-021-06-0F4-SR-000-00-00Model Super Files 21mm F4 6pcs/packRef D-P.03.07-025-07-0F1-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm F1 6pcs/packRef D-P.03.07-031-VT-0A0-SR-000-00-00Model Super Files For Hand Use 31mm SX-F3 6pcs/packRef D-P.01.01-021-09-0F3-SR-000-00-00Model Super Files 21mm F3 6pcs/packRef D-P.03.07-021-07-0F1-SR-000-00-00Model Super Files For Hand Use 21mm F1 6pcs/packRef D-P.01.01-031-VT-0A0-SR-000-00-00Model Super Files 31mm SX-F3 6pcs/packRef D-P.03.07-021-VT-0S2-SR-000-00-00Model Super Files For Hand Use 21mm S2 6pcs/packRef D-P.01.01-031-06-0F4-SR-000-00-00Model Super Files 31mm F4 6pcs/packRef D-P.01.01-025-VT-0A0-SR-000-00-00Model Super Files 25mm SX-F3 6pcs/packRef D-P.03.07-031-VT-0S1-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 31mm S1 6pcs/packRef D-P.03.07-021-07-0F1-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 21mm F1 6pcs/packRef D-P.03.07-021-VT-0S1-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 21mm S1 6pcs/packRef D-P.03.07-021-VT-0S1-SR-000-00-00Model Super Files For Hand Use 21mm S1 6pcs/packRef D-P.03.07-021-06-0F4-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 21mm F4 6pcs/packRef D-P.01.01-025-07-0F1-SR-000-00-00Model Super Files 25mm F1 6pcs/packRef D-P.01.01-021-07-0F1-SR-000-00-00Model Super Files 21mm F1 6pcs/packRef D-P.01.01-031-08-0F2-SR-000-00-00Model Super Files 31mm F2 6pcs/packRef D-P.03.07-025-VT-0A0-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm SX-F3 6pcs/packRef D-P.01.01-031-05-0F5-SR-000-00-00Model Super Files 31mm F5 6pcs/packRef D-P.01.01-031-09-0F3-SR-000-00-00Model Super Files 31mm F3 6pcs/packRef D-P.03.07-031-VT-0S1-SR-000-00-00Model Super Files For Hand Use 31mm S1 6pcs/packRef D-P.03.07-025-VT-0S1-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm S1 6pcs/packRef D-P.01.01-025-07-0F1-BU-000-00-00Model Super Files III 25mm F1 6pcs/packRef D-P.01.01-019-VT-0SX-SR-000-00-00Model Super Files 19mm SX 6pcs/packRef D-P.03.07-025-05-0F5-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm F5 6pcs/packRef D-P.03.07-025-VT-0S2-SR-000-00-00Model Super Files For Hand Use 25mm S2 6pcs/packRef D-P.03.07-025-06-0F4-SR-000-00-00Model Super Files For Hand Use 25mm F4 6pcs/packRef D-P.03.07-031-05-0F5-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 31mm F5 6pcs/packRef D-P.03.07-031-VT-0S2-SR-000-00-00Model Super Files For Hand Use 31mm S2 6pcs/packRef D-P.03.07-021-VT-0A0-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 21mm SX-F3 6pcs/packRef D-P.03.07-025-09-0F3-SR-000-00-00Model Super Files For Hand Use 25mm F3 6pcs/packRef D-P.01.01-031-VT-0S2-RB-000-00-00Model Chameleon Series - Super files 31mm S2 6pcs/packRef D-P.01.01-025-06-0F4-RB-000-00-00Model Chameleon Series - Super files 25mm F4 6pcs/packRef D-P.01.01-021-06-0F4-RB-000-00-00Model Chameleon Series - Super files 21mm F4 6pcs/packRef D-P.01.01-031-06-0F4-RB-000-00-00Model Chameleon Series - Super files 31mm F4 6pcs/packRef D-P.01.01-021-08-0F2-RB-000-00-00Model Chameleon Series - Super files 21mm F2 6pcs/packRef D-P.01.01-025-05-0F5-RB-000-00-00Model Chameleon Series - Super files 25mm F5 6pcs/packRef D-P.01.01-021-07-0F1-RB-000-00-00Model Chameleon Series - Super files 21mm F1 6pcs/packRef D-P.01.01-021-VT-0A0-RB-000-00-00Model Chameleon Series - Super files 21mm SX-F3 6pcs/packRef D-P.01.01-025-VT-0S1-RB-000-00-00Model Chameleon Series - Super files 25mm S1 6pcs/packRef D-P.01.01-025-08-0F2-RB-000-00-00Model Chameleon Series - Super files 25mm F2 6pcs/packRef D-P.01.01-031-08-0F2-RB-000-00-00Model Chameleon Series - Super files 31mm F2 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
Super Files EUDAMED
Super Files III EUDAMED
Denco FDA UDI
Generic Name
Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Device Name
Super Files EUDAMED
Super Files III EUDAMED
Model / Reference
Super Files For Hand Use 25mm SX-F3 6pcs/pack EUDAMED
D-P.03.07-025-VT-0A0-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 21mm F2 6pcs/pack EUDAMED
D-P.03.07-021-08-0F2-RB-000-00-00 EUDAMED
Super Files 25mm F3 6pcs/pack EUDAMED
D-P.01.01-025-09-0F3-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 25mm F2 6pcs/pack EUDAMED
D-P.03.07-025-08-0F2-RB-000-00-00 EUDAMED
Super Files For Hand Use 21mm SX-F3 6pcs/pack EUDAMED
D-P.03.07-021-VT-0A0-SR-000-00-00 EUDAMED
Super Files For Hand Use 25mm F2 6pcs/pack EUDAMED
D-P.03.07-025-08-0F2-SR-000-00-00 EUDAMED
Super Files For Hand Use 21mm F4 6pcs/pack EUDAMED
D-P.03.07-021-06-0F4-SR-000-00-00 EUDAMED
Super Files 31mm S1 6pcs/pack EUDAMED
D-P.01.01-031-VT-0S1-SR-000-00-00 EUDAMED
Super Files 21mm SX-F3 6pcs/pack EUDAMED
D-P.01.01-021-VT-0A0-SR-000-00-00 EUDAMED
Super Files For Hand Use 31mm F5 6pcs/pack EUDAMED
D-P.03.07-031-05-0F5-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 19mm SX 6pcs/pack EUDAMED
D-P.03.07-019-VT-0SX-RB-000-00-00 EUDAMED
Super Files 21mm F2 6pcs/pack EUDAMED
D-P.01.01-021-08-0F2-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 25mm F4 6pcs/pack EUDAMED
D-P.03.07-025-06-0F4-RB-000-00-00 EUDAMED
Super Files 31mm F1 6pcs/pack EUDAMED
D-P.01.01-031-07-0F1-SR-000-00-00 EUDAMED
Super Files 25mm F4 6pcs/pack EUDAMED
D-P.01.01-025-06-0F4-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 21mm F3 6pcs/pack EUDAMED
D-P.03.07-021-09-0F3-RB-000-00-00 EUDAMED
Super Files 21mm F4 6pcs/pack EUDAMED
D-P.01.01-021-06-0F4-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 25mm F1 6pcs/pack EUDAMED
D-P.03.07-025-07-0F1-RB-000-00-00 EUDAMED
Super Files For Hand Use 31mm SX-F3 6pcs/pack EUDAMED
D-P.03.07-031-VT-0A0-SR-000-00-00 EUDAMED
Super Files 21mm F3 6pcs/pack EUDAMED
D-P.01.01-021-09-0F3-SR-000-00-00 EUDAMED
Super Files For Hand Use 21mm F1 6pcs/pack EUDAMED
D-P.03.07-021-07-0F1-SR-000-00-00 EUDAMED
Super Files 31mm SX-F3 6pcs/pack EUDAMED
D-P.01.01-031-VT-0A0-SR-000-00-00 EUDAMED
Super Files For Hand Use 21mm S2 6pcs/pack EUDAMED
D-P.03.07-021-VT-0S2-SR-000-00-00 EUDAMED
Super Files 31mm F4 6pcs/pack EUDAMED
D-P.01.01-031-06-0F4-SR-000-00-00 EUDAMED
Super Files 25mm SX-F3 6pcs/pack EUDAMED
D-P.01.01-025-VT-0A0-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 31mm S1 6pcs/pack EUDAMED
D-P.03.07-031-VT-0S1-RB-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 21mm F1 6pcs/pack EUDAMED
D-P.03.07-021-07-0F1-RB-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 21mm S1 6pcs/pack EUDAMED
D-P.03.07-021-VT-0S1-RB-000-00-00 EUDAMED
Super Files For Hand Use 21mm S1 6pcs/pack EUDAMED
D-P.03.07-021-VT-0S1-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 21mm F4 6pcs/pack EUDAMED
D-P.03.07-021-06-0F4-RB-000-00-00 EUDAMED
Super Files 25mm F1 6pcs/pack EUDAMED
D-P.01.01-025-07-0F1-SR-000-00-00 EUDAMED
Super Files 21mm F1 6pcs/pack EUDAMED
D-P.01.01-021-07-0F1-SR-000-00-00 EUDAMED
Super Files 31mm F2 6pcs/pack EUDAMED
D-P.01.01-031-08-0F2-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 25mm SX-F3 6pcs/pack EUDAMED
D-P.03.07-025-VT-0A0-RB-000-00-00 EUDAMED
Super Files 31mm F5 6pcs/pack EUDAMED
D-P.01.01-031-05-0F5-SR-000-00-00 EUDAMED
Super Files 31mm F3 6pcs/pack EUDAMED
D-P.01.01-031-09-0F3-SR-000-00-00 EUDAMED
Super Files For Hand Use 31mm S1 6pcs/pack EUDAMED
D-P.03.07-031-VT-0S1-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 25mm S1 6pcs/pack EUDAMED
D-P.03.07-025-VT-0S1-RB-000-00-00 EUDAMED
Super Files III 25mm F1 6pcs/pack EUDAMED
D-P.01.01-025-07-0F1-BU-000-00-00 EUDAMED
Super Files 19mm SX 6pcs/pack EUDAMED
D-P.01.01-019-VT-0SX-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 25mm F5 6pcs/pack EUDAMED
D-P.03.07-025-05-0F5-RB-000-00-00 EUDAMED
Super Files For Hand Use 25mm S2 6pcs/pack EUDAMED
D-P.03.07-025-VT-0S2-SR-000-00-00 EUDAMED
Super Files For Hand Use 25mm F4 6pcs/pack EUDAMED
D-P.03.07-025-06-0F4-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 31mm F5 6pcs/pack EUDAMED
D-P.03.07-031-05-0F5-RB-000-00-00 EUDAMED
Super Files For Hand Use 31mm S2 6pcs/pack EUDAMED
D-P.03.07-031-VT-0S2-SR-000-00-00 EUDAMED
Chameleon Series - Super Files For Hand Use 21mm SX-F3 6pcs/pack EUDAMED
D-P.03.07-021-VT-0A0-RB-000-00-00 EUDAMED
Super Files For Hand Use 25mm F3 6pcs/pack EUDAMED
D-P.03.07-025-09-0F3-SR-000-00-00 EUDAMED
Chameleon Series - Super files 31mm S2 6pcs/pack EUDAMED
D-P.01.01-031-VT-0S2-RB-000-00-00 EUDAMED
Chameleon Series - Super files 25mm F4 6pcs/pack EUDAMED
D-P.01.01-025-06-0F4-RB-000-00-00 EUDAMED
Chameleon Series - Super files 21mm F4 6pcs/pack EUDAMED
D-P.01.01-021-06-0F4-RB-000-00-00 EUDAMED
Chameleon Series - Super files 31mm F4 6pcs/pack EUDAMED
D-P.01.01-031-06-0F4-RB-000-00-00 EUDAMED
Chameleon Series - Super files 21mm F2 6pcs/pack EUDAMED
D-P.01.01-021-08-0F2-RB-000-00-00 EUDAMED
Chameleon Series - Super files 25mm F5 6pcs/pack EUDAMED
D-P.01.01-025-05-0F5-RB-000-00-00 EUDAMED
Chameleon Series - Super files 21mm F1 6pcs/pack EUDAMED
D-P.01.01-021-07-0F1-RB-000-00-00 EUDAMED
Chameleon Series - Super files 21mm SX-F3 6pcs/pack EUDAMED
D-P.01.01-021-VT-0A0-RB-000-00-00 EUDAMED
Chameleon Series - Super files 25mm S1 6pcs/pack EUDAMED
D-P.01.01-025-VT-0S1-RB-000-00-00 EUDAMED
Chameleon Series - Super files 25mm F2 6pcs/pack EUDAMED
D-P.01.01-025-08-0F2-RB-000-00-00 EUDAMED
Chameleon Series - Super files 31mm F2 6pcs/pack EUDAMED
D-P.01.01-031-08-0F2-RB-000-00-00 EUDAMED
25mm Super fileIII(Engine) F1 FDA UDI

Identifiers

Primary DI / UDI-DI
06970514912257 EUDAMED
06975718054949 EUDAMED
06970514912448 EUDAMED
06975718055021 EUDAMED
06970514912189 EUDAMED
06970514912226 EUDAMED
06970514912172 EUDAMED
06970514912462 EUDAMED
06970514914152 EUDAMED
06970514910185 EUDAMED
06975718054918 EUDAMED
06970514912370 EUDAMED
06975718055045 EUDAMED
06970514912486 EUDAMED
06970514912455 EUDAMED
06975718054956 EUDAMED
06970514912394 EUDAMED
06975718055014 EUDAMED
06970514912332 EUDAMED
06970514912387 EUDAMED
06970514912141 EUDAMED
06970514910215 EUDAMED
06970514912134 EUDAMED
06970514912523 EUDAMED
06970514914213 EUDAMED
06975718055144 EUDAMED
06975718054932 EUDAMED
06975718054987 EUDAMED
06970514912127 EUDAMED
06975718054963 EUDAMED
06970514912424 EUDAMED
06970514912363 EUDAMED
06970514912493 EUDAMED
06975718055007 EUDAMED
06970514910192 EUDAMED
06970514912509 EUDAMED
06970514912264 EUDAMED
06975718055069 EUDAMED
06970514918785 EUDAMEDFDA UDI
06970514910895 EUDAMED
06975718055052 EUDAMED
06970514912202 EUDAMED
06970514912240 EUDAMED
06975718055137 EUDAMED
06970514912271 EUDAMED
06975718054925 EUDAMED
06970514912233 EUDAMED
06975718053263 EUDAMED
06975718053157 EUDAMED
06975718053072 EUDAMED
06975718053232 EUDAMED
06975718053058 EUDAMED
06975718053164 EUDAMED
06975718053041 EUDAMED
06975718053034 EUDAMED
06975718053171 EUDAMED
06975718053133 EUDAMED
06975718053218 EUDAMED
Basic UDI-DI
B-06970514912257 EUDAMED
B-06975718054949 EUDAMED
B-06970514912448 EUDAMED
B-06975718055021 EUDAMED
B-06970514912189 EUDAMED
B-06970514912226 EUDAMED
B-06970514912172 EUDAMED
B-06970514912462 EUDAMED
B-06970514914152 EUDAMED
B-06970514910185 EUDAMED
B-06975718054918 EUDAMED
B-06970514912370 EUDAMED
B-06975718055045 EUDAMED
B-06970514912486 EUDAMED
B-06970514912455 EUDAMED
B-06975718054956 EUDAMED
B-06970514912394 EUDAMED
B-06975718055014 EUDAMED
B-06970514912332 EUDAMED
B-06970514912387 EUDAMED
B-06970514912141 EUDAMED
B-06970514910215 EUDAMED
B-06970514912134 EUDAMED
B-06970514912523 EUDAMED
B-06970514914213 EUDAMED
B-06975718055144 EUDAMED
B-06975718054932 EUDAMED
B-06975718054987 EUDAMED
B-06970514912127 EUDAMED
B-06975718054963 EUDAMED
B-06970514912424 EUDAMED
B-06970514912363 EUDAMED
B-06970514912493 EUDAMED
B-06975718055007 EUDAMED
B-06970514910192 EUDAMED
B-06970514912509 EUDAMED
B-06970514912264 EUDAMED
B-06975718055069 EUDAMED
B-06970514918785 EUDAMED
B-06970514910895 EUDAMED
B-06975718055052 EUDAMED
B-06970514912202 EUDAMED
B-06970514912240 EUDAMED
B-06975718055137 EUDAMED
B-06970514912271 EUDAMED
B-06975718054925 EUDAMED
B-06970514912233 EUDAMED
B-06975718053263 EUDAMED
B-06975718053157 EUDAMED
B-06975718053072 EUDAMED
B-06975718053232 EUDAMED
B-06975718053058 EUDAMED
B-06975718053164 EUDAMED
B-06975718053041 EUDAMED
B-06975718053034 EUDAMED
B-06975718053171 EUDAMED
B-06975718053133 EUDAMED
B-06975718053218 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
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

Super 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 884c26e3-628f-4447-8d4a-b8469896787f 61 fields · synced Sep 17, 2026
  • EUDAMED 1ce9a705-13d2-4c43-8e65-b852b3c405bf 61 fields · synced May 16, 2026
  • EUDAMED a05e7c67-c1ac-418f-a30b-277f1ce1313a 61 fields · synced May 16, 2026
  • EUDAMED 9378c136-9c20-4a04-92a2-d072650b25c9 61 fields · synced May 16, 2026
  • EUDAMED 2cbb9105-53c0-4288-aa72-f79ed376f190 61 fields · synced May 16, 2026
  • EUDAMED 50a3180d-80e8-43d0-81fe-48ba90bb1c41 61 fields · synced May 16, 2026
  • EUDAMED 7bda2762-c0c3-4666-89a8-2b990660866d 61 fields · synced May 16, 2026
  • EUDAMED eae8acac-8d43-47f6-87f2-e88124eccbe3 61 fields · synced May 16, 2026
  • EUDAMED 6a2d9931-2621-4572-a873-2e164e6f8763 61 fields · synced May 17, 2026
  • EUDAMED b9834823-0c99-4ccd-a60f-fac77a7269e0 61 fields · synced May 17, 2026
  • EUDAMED 6f1bde6e-7046-4ce7-9904-cbc4b34738a1 61 fields · synced May 17, 2026
  • EUDAMED ff7e763e-900f-4b1a-ad06-c2d6ae72cd28 61 fields · synced May 17, 2026
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