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S.S C+ Files
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CODE482108Model E48 S.S C+ Files 6s 21mm No.08Ref CODE482110Model E48 S.S C+ Files 6s 21mm No.10Ref CODE482106Model E48 S.S C+ Files 6s 21mm No.06Ref CODE4821ASSTModel E48 S.S C+ Files 6s 21mm Asst.Ref D-P.02.06-031-02-010-SR-000-00-00Model S.S C+ FILES 31mm #10 6pcs/blisterRef D-P.02.06-025-02-0A0-SR-000-00-00Model S.S C+ FILES 25mm #06-#10 6pcs/blisterRef D-P.02.06-025-02-015-SR-000-00-00Model S.S C+ FILES 25mm #15 6pcs/blisterRef D-P.02.06-025-02-125-SR-000-00-00Model S.S C+ FILES 25mm #12.5 6pcs/blisterRef D-P.02.06-021-02-015-SR-000-00-00Model S.S C+ FILES 21mm #15 6pcs/blisterRef D-P.02.06-021-02-125-SR-000-00-00Model S.S C+ FILES 21mm #12.5 6pcs/blisterRef D-P.02.06-021-02-010-SR-000-00-00Model S.S C+ FILES 21mm #10 6pcs/blisterRef D-P.02.06-025-02-010-SR-000-00-00Model S.S C+ FILES 25mm #10 6pcs/blisterRef D-P.02.06-025-02-008-SR-000-00-00Model S.S C+ FILES 25mm #08 6pcs/blister
Identity
- Trade Name
- S.S C+ Files EUDAMEDDenco FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Dental Root Canal Instruments Reamers EUDAMEDS.S C+ FILES EUDAMED
- Model / Reference
- E48 S.S C+ Files 6s 21mm No.08 EUDAMEDCODE482108 EUDAMEDE48 S.S C+ Files 6s 21mm No.10 EUDAMEDCODE482110 EUDAMEDE48 S.S C+ Files 6s 21mm No.06 EUDAMEDCODE482106 EUDAMEDE48 S.S C+ Files 6s 21mm Asst. EUDAMEDCODE4821ASST EUDAMEDS.S C+ FILES 31mm #10 6pcs/blister EUDAMEDD-P.02.06-031-02-010-SR-000-00-00 EUDAMEDS.S C+ FILES 25mm #06-#10 6pcs/blister EUDAMEDD-P.02.06-025-02-0A0-SR-000-00-00 EUDAMEDS.S C+ FILES 25mm #15 6pcs/blister EUDAMEDD-P.02.06-025-02-015-SR-000-00-00 EUDAMEDS.S C+ FILES 25mm #12.5 6pcs/blister EUDAMEDD-P.02.06-025-02-125-SR-000-00-00 EUDAMEDS.S C+ FILES 21mm #15 6pcs/blister EUDAMEDD-P.02.06-021-02-015-SR-000-00-00 EUDAMEDS.S C+ FILES 21mm #12.5 6pcs/blister EUDAMEDD-P.02.06-021-02-125-SR-000-00-00 EUDAMEDS.S C+ FILES 21mm #10 6pcs/blister EUDAMEDD-P.02.06-021-02-010-SR-000-00-00 EUDAMEDS.S C+ FILES 25mm #10 6pcs/blister EUDAMEDD-P.02.06-025-02-010-SR-000-00-00 EUDAMEDS.S C+ FILES 25mm #08 6pcs/blister EUDAMEDD-P.02.06-025-02-008-SR-000-00-00 EUDAMED25mm C+ FILES #6-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942512506448 EUDAMED06942512506455 EUDAMED06942512506431 EUDAMED06942512506486 EUDAMED06970514910109 EUDAMEDFDA UDI06970514912622 EUDAMED06970514912592 EUDAMED06970514919508 EUDAMED06970514912554 EUDAMED06975718055915 EUDAMED06970514912547 EUDAMED06970514912585 EUDAMED06970514912578 EUDAMED
- Basic UDI-DI
- B-06942512506448 EUDAMEDB-06942512506455 EUDAMEDB-06942512506431 EUDAMEDB-06942512506486 EUDAMEDB-06970514912622 EUDAMEDB-06970514910109 EUDAMEDB-06970514912592 EUDAMEDB-06970514919508 EUDAMEDB-06970514912554 EUDAMEDB-06975718055915 EUDAMEDB-06970514912547 EUDAMEDB-06970514912585 EUDAMEDB-06970514912578 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 EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Poland EUDAMEDTürkiye 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
Moist Heat or Steam Sterilization FDA UDI
S.S C+ 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942512506448 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (14)
- EUDAMED 7b569f92-6c6d-446b-b36b-a08cb69ed225 61 fields · synced Aug 3, 2026
- EUDAMED 7a465a91-2b74-4054-9c1a-a710fc436da9 61 fields · synced May 17, 2026
- EUDAMED 39ea4bb3-614e-462d-a241-1d314ff63452 61 fields · synced May 17, 2026
- EUDAMED 0d582fb2-0acb-42d3-8371-117ced7ab617 61 fields · synced May 18, 2026
- FDA UDI 4c451c93-3b2f-43b0-b43d-813bd9c92069 33 fields · synced May 30, 2026
- EUDAMED 3377dcfe-5b34-4481-b69b-c136fa6e6fc5 61 fields · synced Jun 20, 2026
- EUDAMED d0575255-8015-4bbd-a957-5b02e4d271e8 61 fields · synced Jul 13, 2026
- EUDAMED 78a0fff2-c9ff-4184-9dd0-fc782a4a7be4 61 fields · synced Jul 15, 2026
- EUDAMED f651f362-2542-40a7-a00c-a1c9a3b8cc07 61 fields · synced Jul 16, 2026
- EUDAMED 68578d06-a77a-4340-aa1a-090a679d4157 61 fields · synced Jul 16, 2026
- EUDAMED 5a2314d7-ec65-4661-8147-a44bf13090e8 61 fields · synced Jul 18, 2026
- EUDAMED 9ebdd663-f52d-4703-9a3d-21591479b217 61 fields · synced Jul 21, 2026
- EUDAMED ec33ead3-b16d-46e1-8ff7-cef6ccc64c87 61 fields · synced Aug 2, 2026
- EUDAMED c1f3b951-015d-43fc-b26e-fd96d12c079b 61 fields · synced Aug 3, 2026