KP-1708-19 KP-16vt-25 KP-2004-25 KP-2504-25 KP-2506-25

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref /Model KP,DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E

by Guilin Kevin Peter Technology Co., Ltd.

Identity

Trade Name: KP-1708-19 KP-16vt-25 KP-2004-25 KP-2504-25 KP-2506-25 EUDAMED
KP FDA UDI
Generic Name: Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
Device Name: Root Canal File EUDAMED
Model / Reference: KP,DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E EUDAMED
/ EUDAMED
KP-1708-19 KP-16vt-25 KP-2004-25 KP-2504-25 KP-2506-25 FDA UDI

Identifiers

Primary DI / UDI-DI: 06975384334307 EUDAMEDFDA UDI
Basic UDI-DI: 69753843302YN EUDAMED
FDA Product Code: EKS FDA UDI
EMDN Code: L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
GMDN Term: Rotary/reciprocating endodontic file/rasp, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic file/rasp, reusable

KP-1708-19 KP-16vt-25 KP-2004-25 KP-2504-25 KP-2506-25 by Guilin Kevin Peter Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Manual endodontic file/rasp, reusable.

K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
REAMERS — DiaDent Group International · Class I
K-Files — MICRO MEGA · Class I
Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	69753843302YN	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Guilin Kevin Peter Technology Co., Ltd.
EUDAMED SRN: CN-MF-000022934
Authorised Representative: MedNet EC-REP C IIb GmbH DE-AR-000011194

Sources (2)

EUDAMED 742d7220-6eab-4c1e-9160-ced1028cf21a 61 fields · synced Oct 6, 2026
FDA UDI b83ba019-50fd-4824-90c6-4dc12f4516ed 32 fields · synced May 30, 2026