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Denco

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref D-P.02.01-031-02-008-SR-000-00-00Model S.S.K-Files 31mm #08 6pcs/pack

by Shenzhen Denco Medical Co., Ltd

Identity

Trade Name
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
Model / Reference
S.S.K-Files 31mm #08 6pcs/pack EUDAMED
D-P.02.01-031-02-008-SR-000-00-00 EUDAMED
31mm Stainless Steel K-FILES (Hand Use) #08 FDA UDI

Identifiers

Primary DI / UDI-DI
06970514916606 EUDAMEDFDA UDI
Basic UDI-DI
B-06970514916606 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
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

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Denco Medical Co., Ltd

Sources (2)

  • FDA UDI 24436c05-1668-4bcf-bbfb-e83a31519f9a 33 fields · synced Jun 18, 2026
  • EUDAMED affe68d9-6bcd-411e-a559-0652190c6e7c 61 fields · synced Jun 18, 2026