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Endodontic Stainless Steel Hand Files

EUDAMEDFDA UDI

Class I (EU MDR)

Ref SS501-102Ref REAMERS 31mm #70 / SS501-313Ref HEDSTROM FILES 21mm #35 / SS503-107Ref K-FILES 21mm #40 / SS502-108Ref REAMERS 21mm #45/80 / SS501-192Ref HEDSTROM FILES 25mm #30 / SS503-206Ref K-FILES 21mm #10 / SS502-102Ref K-FILES 21mm #80 / SS502-114Ref HEDSTROM FILES 25mm #50 / SS503-210Ref K-FILES 25mm #45 / SS502-209Ref HEDSTROM FILES 31mm #15/40 / SS503-391Ref K-FILES 31mm #8 / SS502-301Ref REAMERS 21mm #20 / SS501-104Ref HEDSTROM FILES 21mm #40 / SS503-108Ref HEDSTROM FILES 31mm #45/80 / SS503-392Ref REAMERS 21mm #80 / SS501-114Ref K-FILES 25mm #40 / SS502-208Ref HEDSTROM FILES 31mm #10 / SS503-302Ref REAMERS 25mm #35 / SS501-207Ref REAMERS 21mm #35 / SS501-107Ref REAMERS 31mm #60 / SS501-312Ref K-FILES 31mm #45 / SS502-309Ref REAMERS 25mm #25 / SS501-205Ref K-FILES 31mm #50 / SS502-310Ref SS501-103Ref HEDSTROM FILES 25mm #10 / SS503-202Ref REAMERS 21mm #60 / SS501-112Ref K-FILES 25mm #8 / SS502-201Ref K-FILES 31mm #40 / SS502-308Ref HEDSTROM FILES 21mm #80 / SS503-114Ref HEDSTROM FILES 25mm #15/40 / SS503-291Ref K-FILES 21mm #55 / SS502-111Ref REAMERS 25mm #55 / SS501-211Ref HEDSTROM FILES 21mm #25 / SS503-105Ref K-FILES 21mm #50 / SS502-110Ref K-FILES 25mm #80 / SS502-214Ref K-FILES 31mm #20 / SS502-304Ref K-FILES 21mm #45/80 / SS502-192Ref REAMERS 31mm #55 / SS501-311Ref K-FILES 25mm #70 / SS502-213Ref K-FILES 21mm #45 / SS502-109Ref HEDSTROM FILES 25mm #20 / SS503-204Ref HEDSTROM FILES 25mm #70 / SS503-213Ref REAMERS 25mm #80 / SS501-214Ref HEDSTROM FILES 21mm #60 / SS503-112Ref HEDSTROM FILES 25mm #45/80 / SS503-292Ref REAMERS 21mm #70 / SS501-113Ref K-FILES 31mm #15 / SS502-303Ref REAMERS 25mm #10 / SS501-202Ref HEDSTROM FILES 21mm #55 / SS503-111Ref K-FILES 31mm #30 / SS502-306Ref HEDSTROM FILES 25mm #60 / SS503-212Ref K-FILES 25mm #60 / SS502-212Ref REAMERS 25mm #15 / SS501-203Ref HEDSTROM FILES 21mm #15/40 / SS503-191Ref REAMERS 31mm #35 / SS501-307Ref HEDSTROM FILES 31mm #40 / SS503-308Ref HEDSTROM FILES 21mm #45 / SS503-109Ref HEDSTROM FILES 31mm #45 / SS503-309Ref HEDSTROM FILES 21mm #30 / SS503-106Ref K-FILES 21mm #25 / SS502-105Ref REAMERS 25mm #40 / SS501-208Ref K-FILES 21mm #30 / SS502-106Ref REAMERS 21mm #40 / SS501-108Ref K-FILES 31mm #15/40 / SS502-391Ref REAMERS 31mm #10 / SS501-302Ref K-FILES 21mm #70 / SS502-113Ref K-FILES 31mm #35 / SS502-307Ref REAMERS 25mm #60 / SS501-212Ref HEDSTROM FILES 25mm #55 / SS503-211Ref REAMERS 25mm #20 / SS501-204Ref REAMERS 25mm #8 / SS501-201Ref REAMERS 31mm #45 / SS501-309Ref K-FILES 25mm #15 / SS502-203Ref REAMERS 31mm #15 / SS501-303Ref K-FILES 31mm #80 / SS502-314Ref REAMERS 21mm #30 / SS501-106Ref K-FILES 21mm #15 / SS502-103

by Diadent Group International

Identity

Trade Name
ENDODONTIC STAINLESS STEEL HAND FILES EUDAMED
K-FILES FDA UDI
H-FILES FDA UDI
REAMERS FDA UDI
Generic Name
Manual endodontic file/rasp, reusable FDA UDI
Device Name
ENDODONTIC INSTRUMENTS EUDAMED
Files are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
REAMERS are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
Model / Reference
SS501-102 EUDAMED
REAMERS 31mm #70 / SS501-313 EUDAMED
HEDSTROM FILES 21mm #35 / SS503-107 EUDAMED
K-FILES 21mm #40 / SS502-108 EUDAMED
REAMERS 21mm #45/80 / SS501-192 EUDAMED
HEDSTROM FILES 25mm #30 / SS503-206 EUDAMED
K-FILES 21mm #10 / SS502-102 EUDAMED
K-FILES 21mm #80 / SS502-114 EUDAMED
HEDSTROM FILES 25mm #50 / SS503-210 EUDAMED
K-FILES 25mm #45 / SS502-209 EUDAMED
HEDSTROM FILES 31mm #15/40 / SS503-391 EUDAMED
K-FILES 31mm #8 / SS502-301 EUDAMED
REAMERS 21mm #20 / SS501-104 EUDAMED
HEDSTROM FILES 21mm #40 / SS503-108 EUDAMED
HEDSTROM FILES 31mm #45/80 / SS503-392 EUDAMED
REAMERS 21mm #80 / SS501-114 EUDAMED
K-FILES 25mm #40 / SS502-208 EUDAMED
HEDSTROM FILES 31mm #10 / SS503-302 EUDAMED
REAMERS 25mm #35 / SS501-207 EUDAMED
REAMERS 21mm #35 / SS501-107 EUDAMED
REAMERS 31mm #60 / SS501-312 EUDAMED
K-FILES 31mm #45 / SS502-309 EUDAMED
REAMERS 25mm #25 / SS501-205 EUDAMED
K-FILES 31mm #50 / SS502-310 EUDAMED
SS501-103 EUDAMED
HEDSTROM FILES 25mm #10 / SS503-202 EUDAMED
REAMERS 21mm #60 / SS501-112 EUDAMED
K-FILES 25mm #8 / SS502-201 EUDAMED
K-FILES 31mm #40 / SS502-308 EUDAMED
HEDSTROM FILES 21mm #80 / SS503-114 EUDAMED
HEDSTROM FILES 25mm #15/40 / SS503-291 EUDAMED
K-FILES 21mm #55 / SS502-111 EUDAMED
REAMERS 25mm #55 / SS501-211 EUDAMED
HEDSTROM FILES 21mm #25 / SS503-105 EUDAMED
K-FILES 21mm #50 / SS502-110 EUDAMED
K-FILES 25mm #80 / SS502-214 EUDAMED
K-FILES 31mm #20 / SS502-304 EUDAMED
K-FILES 21mm #45/80 / SS502-192 EUDAMED
REAMERS 31mm #55 / SS501-311 EUDAMED
K-FILES 25mm #70 / SS502-213 EUDAMED
K-FILES 21mm #45 / SS502-109 EUDAMED
HEDSTROM FILES 25mm #20 / SS503-204 EUDAMED
HEDSTROM FILES 25mm #70 / SS503-213 EUDAMED
REAMERS 25mm #80 / SS501-214 EUDAMED
HEDSTROM FILES 21mm #60 / SS503-112 EUDAMED
HEDSTROM FILES 25mm #45/80 / SS503-292 EUDAMED
REAMERS 21mm #70 / SS501-113 EUDAMED
K-FILES 31mm #15 / SS502-303 EUDAMED
REAMERS 25mm #10 / SS501-202 EUDAMED
HEDSTROM FILES 21mm #55 / SS503-111 EUDAMED
K-FILES 31mm #30 / SS502-306 EUDAMED
HEDSTROM FILES 25mm #60 / SS503-212 EUDAMED
K-FILES 25mm #60 / SS502-212 EUDAMED
REAMERS 25mm #15 / SS501-203 EUDAMED
HEDSTROM FILES 21mm #15/40 / SS503-191 EUDAMED
REAMERS 31mm #35 / SS501-307 EUDAMED
HEDSTROM FILES 31mm #40 / SS503-308 EUDAMED
HEDSTROM FILES 21mm #45 / SS503-109 EUDAMED
HEDSTROM FILES 31mm #45 / SS503-309 EUDAMED
HEDSTROM FILES 21mm #30 / SS503-106 EUDAMED
K-FILES 21mm #25 / SS502-105 EUDAMED
REAMERS 25mm #40 / SS501-208 EUDAMED
K-FILES 21mm #30 / SS502-106 EUDAMED
REAMERS 21mm #40 / SS501-108 EUDAMED
K-FILES 31mm #15/40 / SS502-391 EUDAMED
REAMERS 31mm #10 / SS501-302 EUDAMED
K-FILES 21mm #70 / SS502-113 EUDAMED
K-FILES 31mm #35 / SS502-307 EUDAMED
REAMERS 25mm #60 / SS501-212 EUDAMED
HEDSTROM FILES 25mm #55 / SS503-211 EUDAMED
REAMERS 25mm #20 / SS501-204 EUDAMED
REAMERS 25mm #8 / SS501-201 EUDAMED
REAMERS 31mm #45 / SS501-309 EUDAMED
K-FILES 25mm #15 / SS502-203 EUDAMED
REAMERS 31mm #15 / SS501-303 EUDAMED
K-FILES 31mm #80 / SS502-314 EUDAMED
REAMERS 21mm #30 / SS501-106 EUDAMED
K-FILES 21mm #15 / SS502-103 EUDAMED
31m/m ASST 15/40 FDA UDI
31m/m 50 FDA UDI
25m/m 60 FDA UDI
25m/m ASST 15/40 FDA UDI
25m/m 10 FDA UDI
31m/m 45 FDA UDI
21m/m 50 FDA UDI
25m/m 80 FDA UDI
31m/m 80 FDA UDI
21m/m 55 FDA UDI
25m/m 40 FDA UDI
31m/m 35 FDA UDI
21m/m 35 FDA UDI
25m/m 35 FDA UDI
21m/m 30 FDA UDI
31m/m 40 FDA UDI
25m/m 20 FDA UDI
21m/m 40 FDA UDI
21m/m 25 FDA UDI
21m/m 60 FDA UDI
31m/m 15 FDA UDI
31m/m 8 FDA UDI
21m/m ASST 15/40 FDA UDI
21m/m 45 FDA UDI
21m/m 70 FDA UDI
31m/m 55 FDA UDI
25m/m 55 FDA UDI
21m/m 80 FDA UDI
21m/m ASST 45/80 FDA UDI
31m/m 70 FDA UDI
25m/m 8 FDA UDI
25m/m 15 FDA UDI
21m/m 10 FDA UDI
21m/m 15 FDA UDI
25m/m 70 FDA UDI
31m/m 10 FDA UDI
25m/m 45 FDA UDI
25m/m ASST 45/80 FDA UDI
31m/m 30 FDA UDI
25m/m 25 FDA UDI
25m/m 30 FDA UDI
25m/m 50 FDA UDI
31m/m 60 FDA UDI
21m/m 20 FDA UDI
31m/m 20 FDA UDI
31m/m ASST 45/80 FDA UDI
Description
Files are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
REAMERS are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI

Identifiers

Catalog Number
SS502-391 FDA UDI
SS502-310 FDA UDI
SS502-212 FDA UDI
SS503-291 FDA UDI
SS503-391 FDA UDI
SS503-202 FDA UDI
SS502-309 FDA UDI
SS502-110 FDA UDI
SS502-214 FDA UDI
SS502-314 FDA UDI
SS503-111 FDA UDI
SS501-208 FDA UDI
SS501-307 FDA UDI
SS503-107 FDA UDI
SS501-207 FDA UDI
SS502-106 FDA UDI
SS502-308 FDA UDI
SS501-204 FDA UDI
SS501-108 FDA UDI
SS503-105 FDA UDI
SS501-112 FDA UDI
SS502-303 FDA UDI
SS502-301 FDA UDI
SS503-191 FDA UDI
SS503-109 FDA UDI
SS501-113 FDA UDI
SS501-311 FDA UDI
SS502-307 FDA UDI
SS503-211 FDA UDI
SS502-114 FDA UDI
SS501-192 FDA UDI
SS501-313 FDA UDI
SS503-106 FDA UDI
SS502-201 FDA UDI
SS503-108 FDA UDI
SS502-113 FDA UDI
SS502-208 FDA UDI
SS501-203 FDA UDI
SS503-114 FDA UDI
SS502-102 FDA UDI
SS502-105 FDA UDI
SS502-192 FDA UDI
SS501-309 FDA UDI
SS501-212 FDA UDI
SS503-308 FDA UDI
SS502-103 FDA UDI
SS503-213 FDA UDI
SS503-112 FDA UDI
SS501-103 FDA UDI
SS501-114 FDA UDI
SS501-302 FDA UDI
SS502-109 FDA UDI
SS503-212 FDA UDI
SS502-209 FDA UDI
SS501-107 FDA UDI
SS501-202 FDA UDI
SS502-203 FDA UDI
SS503-292 FDA UDI
SS501-106 FDA UDI
SS502-306 FDA UDI
SS503-204 FDA UDI
SS502-108 FDA UDI
SS501-205 FDA UDI
SS501-102 FDA UDI
SS503-302 FDA UDI
SS503-309 FDA UDI
SS503-206 FDA UDI
SS501-201 FDA UDI
SS502-111 FDA UDI
SS501-214 FDA UDI
SS503-210 FDA UDI
SS501-303 FDA UDI
SS501-211 FDA UDI
SS501-312 FDA UDI
SS501-104 FDA UDI
SS502-213 FDA UDI
SS502-304 FDA UDI
SS503-392 FDA UDI
Primary DI / UDI-DI
08806383537728 EUDAMEDFDA UDI
08806383536998 EUDAMEDFDA UDI
08806383536882 EUDAMEDFDA UDI
08806383536677 EUDAMEDFDA UDI
08806383537452 EUDAMEDFDA UDI
08806383537681 EUDAMEDFDA UDI
08806383537261 EUDAMEDFDA UDI
08806383536875 EUDAMEDFDA UDI
08806383536424 EUDAMEDFDA UDI
08806383536691 EUDAMEDFDA UDI
08806383536929 EUDAMEDFDA UDI
08806383537124 EUDAMEDFDA UDI
08806383538015 EUDAMEDFDA UDI
08806383538237 EUDAMEDFDA UDI
08806383537087 EUDAMEDFDA UDI
08806383538008 EUDAMEDFDA UDI
08806383536387 EUDAMEDFDA UDI
08806383536868 EUDAMEDFDA UDI
08806383537971 EUDAMEDFDA UDI
08806383537780 EUDAMEDFDA UDI
08806383537063 EUDAMEDFDA UDI
08806383537827 EUDAMEDFDA UDI
08806383536813 EUDAMEDFDA UDI
08806383536790 EUDAMEDFDA UDI
08806383537223 EUDAMEDFDA UDI
08806383537100 EUDAMEDFDA UDI
08806383537834 EUDAMEDFDA UDI
08806383538275 EUDAMEDFDA UDI
08806383536851 EUDAMEDFDA UDI
08806383537353 EUDAMEDFDA UDI
08806383536462 EUDAMEDFDA UDI
08806383537926 EUDAMEDFDA UDI
08806383538299 EUDAMEDFDA UDI
08806383537070 EUDAMEDFDA UDI
08806383536561 EUDAMEDFDA UDI
08806383537094 EUDAMEDFDA UDI
08806383536455 EUDAMEDFDA UDI
08806383536639 EUDAMEDFDA UDI
08806383537964 EUDAMEDFDA UDI
08806383537155 EUDAMEDFDA UDI
08806383536349 EUDAMEDFDA UDI
08806383536370 EUDAMEDFDA UDI
08806383536547 EUDAMEDFDA UDI
08806383538251 EUDAMEDFDA UDI
08806383538053 EUDAMEDFDA UDI
08806383537551 EUDAMEDFDA UDI
08806383536356 EUDAMEDFDA UDI
08806383537377 EUDAMEDFDA UDI
08806383537131 EUDAMEDFDA UDI
08806383537735 EUDAMEDFDA UDI
08806383537841 EUDAMEDFDA UDI
08806383538183 EUDAMEDFDA UDI
08806383536417 EUDAMEDFDA UDI
08806383537360 EUDAMEDFDA UDI
08806383536646 EUDAMEDFDA UDI
08806383537773 EUDAMEDFDA UDI
08806383537957 EUDAMEDFDA UDI
08806383536585 EUDAMEDFDA UDI
08806383537469 EUDAMEDFDA UDI
08806383537766 EUDAMEDFDA UDI
08806383536844 EUDAMEDFDA UDI
08806383537285 EUDAMEDFDA UDI
08806383536400 EUDAMEDFDA UDI
08806383537988 EUDAMEDFDA UDI
08806383537490 EUDAMEDFDA UDI
08806383537568 EUDAMEDFDA UDI
08806383537308 EUDAMEDFDA UDI
08806383537940 EUDAMEDFDA UDI
08806383536431 EUDAMEDFDA UDI
08806383538077 EUDAMEDFDA UDI
08806383537346 EUDAMEDFDA UDI
08806383538190 EUDAMEDFDA UDI
08806383538046 EUDAMEDFDA UDI
08806383538282 EUDAMEDFDA UDI
08806383537742 EUDAMEDFDA UDI
08806383536684 EUDAMEDFDA UDI
08806383536820 EUDAMEDFDA UDI
08806383537698 EUDAMEDFDA UDI
Basic UDI-DI
88063835EIF3J EUDAMED
FDA Product Code
EKS FDA UDI
EMDN Code
L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
GMDN Term
Manual endodontic file/rasp, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.4565 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, reusable

Endodontic Stainless Steel Hand Files by Diadent Group International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic file/rasp, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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

Manufacturer

EUDAMED SRN
KR-MF-000023806
Authorised Representative
Diadent Europe B.V. NL-AR-000012597

Sources (156)

  • EUDAMED a68c32d0-2064-461a-baba-fb27c940c6e8 61 fields · synced Sep 18, 2026
  • FDA UDI 0236894a-ca14-4370-a8cf-bb3a47af2357 34 fields · synced May 22, 2026
  • FDA UDI 812ed153-f3d0-4ee6-97b1-d5b6c30116fb 34 fields · synced May 24, 2026
  • FDA UDI 2f574348-be73-495e-aea6-bac7fe96656f 34 fields · synced May 24, 2026
  • FDA UDI daec2f5f-ab4c-42a9-94f5-81279c00d6ba 34 fields · synced May 24, 2026
  • FDA UDI ba182328-f90e-4646-8c8c-2e909a7291e1 34 fields · synced May 24, 2026
  • FDA UDI efedf8d3-c8c2-476c-b5ff-9019dfe75b63 34 fields · synced May 25, 2026
  • FDA UDI 48bca1dc-9a57-401f-a351-8f8d107cffd2 34 fields · synced May 25, 2026
  • FDA UDI 9f60636c-c6d2-45f9-8ead-5cb2168d29c0 34 fields · synced May 25, 2026
  • FDA UDI aa050699-d2b3-423a-bb93-dddffd96ed92 34 fields · synced May 25, 2026
  • FDA UDI 20c05016-ed5d-44ca-8396-afaefe6543a2 34 fields · synced May 27, 2026
  • FDA UDI 33c692d7-27fc-402b-b425-89780aab0300 34 fields · synced May 29, 2026
  • FDA UDI aae719fe-f87e-482c-94ac-7b7eaacd591f 34 fields · synced May 29, 2026
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  • FDA UDI e4f0e1d9-f9dd-4fd2-a875-bcb0b234c17b 34 fields · synced May 30, 2026
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  • FDA UDI c6cbaf91-964d-4039-9e63-5ff98c045672 34 fields · synced May 30, 2026
  • FDA UDI f677787c-081f-4b55-9c06-32599b95fede 34 fields · synced May 30, 2026
  • FDA UDI 2bc2ec06-88e2-43f7-ab76-8ff37e415a60 34 fields · synced May 30, 2026
  • FDA UDI d5345d5a-12f7-40aa-8d0d-146fa44e1483 34 fields · synced May 30, 2026
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