KP-1708-19 KP-16vt-31 KP-2004-31 KP-2504-31 KP-2506-31

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-31 KP-2004-31 KP-2504-31 KP-2506-31 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-31 KP-2004-31 KP-2504-31 KP-2506-31 FDA UDI

Identifiers

Primary DI / UDI-DI: 06975384334314 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-31 KP-2004-31 KP-2504-31 KP-2506-31 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

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

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 3e11807c-bacc-4015-b97f-460eb580f255 61 fields · synced Oct 6, 2026
FDA UDI cd3c602d-f57e-4949-9f8a-e1f8b4e28519 32 fields · synced May 30, 2026