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K Files

by Shanwei Perfect Medical Instruments Co., Ltd. 340 variants

Ref A330 650 926 2102 006, A330 650 926 2502 006, A330 650 937 2102 006, A330 650 922 2102 006, A330 650 937 2102 032, A330 650 922 2802 100, SA330 650 937 3102 015, A330 650 926 2102 006、A330 650 926 2102 008、A330 650 926 2102 010, A3306509372502045、A3306509372502050、A3306509372502055、A3306509372502060、A3306509372502070、A3306509372502080, A330 650 937 2802 110, A3306509262502090、A3306509262502100、A3306509262502110、A3306509262502120、A3306509262502130、A3306509262502140, SA330 650 926 3102 030, A330 650 937 2802 040, A330 650 922 3102 027, A330 650 926 3102 120, A330 650 922 3102 090, SA330 650 937 3102 070, A330 650 926 2502 120, A330 650 922 2102 022, A3306509262502006、A3306509262502008、A3306509262502010、A3306509262502015、A3306509262502020、A3306509262502025, SA3306509262802008、SA3306509262802010、SA3306509262802015、SA3306509262802020、SA3306509262802025、SA3306509262802030, A330 650 937 2502 025, A330 650 926 2502 030, A330 650 926 3102 090, A330 650 922 2502 010, A330 650 926 2102 035, SA330 650 937 2502 070, A330 650 926 2102 008, SA330 650 937 2802 070, SA330 650 937 2102 055, SA330 650 937 2802 045, A3306509372502015、A3306509372502020、A3306509372502025、A3306509372502030、A3306509372502035、A3306509372502040, A330 650 937 2102 040, A330 650 926 2502 035, SA330 650 937 2502 040, A330 650 937 3102 025, SA330 650 926 2102 025, A330 650 926 2102 027, SA330 650 937 2102 006、SA330 650 937 2102 008、SA330 650 937 2102 010, A490 201 974 2502 040, A490 650 922 3102 008, A330 650 922 2802 010, 025 05, 070 05, A4906509262502045、A4906509262502050、A4906509262502055、A4906509262502060、A4906509262502070、A4906509262502080, A490 650 926 2502 030, A490 650 922 3102 010, A497 201 974 2102 035, A490 650 926 3102 140Model File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc, ET Files、V BLUE、MTF、TG6、TH6、TF4 etc, 02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697590932SSTHandfilesJ4 Basic UDI-DI Date18 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
K Files
H Files
Reamers
/
Device Name
Dental Root-Canal Instruments
Absorbent Paper Points
Model / Reference
File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc, A330 650 926 2102 006, A330 650 926 2502 006, A330 650 937 2102 006, A330 650 922 2102 006, A330 650 937 2102 032, A330 650 922 2802 100, SA330 650 937 3102 015, A330 650 926 2102 006、A330 650 926 2102 008、A330 650 926 2102 010, A3306509372502045、A3306509372502050、A3306509372502055、A3306509372502060、A3306509372502070、A3306509372502080, A330 650 937 2802 110, A3306509262502090、A3306509262502100、A3306509262502110、A3306509262502120、A3306509262502130、A3306509262502140, SA330 650 926 3102 030, A330 650 937 2802 040, A330 650 922 3102 027, A330 650 926 3102 120, A330 650 922 3102 090, SA330 650 937 3102 070, A330 650 926 2502 120, A330 650 922 2102 022, A3306509262502006、A3306509262502008、A3306509262502010、A3306509262502015、A3306509262502020、A3306509262502025, SA3306509262802008、SA3306509262802010、SA3306509262802015、SA3306509262802020、SA3306509262802025、SA3306509262802030, A330 650 937 2502 025, A330 650 926 2502 030, A330 650 926 3102 090, A330 650 922 2502 010, A330 650 926 2102 035, SA330 650 937 2502 070, A330 650 926 2102 008, SA330 650 937 2802 070, SA330 650 937 2102 055, SA330 650 937 2802 045, A3306509372502015、A3306509372502020、A3306509372502025、A3306509372502030、A3306509372502035、A3306509372502040, A330 650 937 2102 040, A330 650 926 2502 035, SA330 650 937 2502 040, A330 650 937 3102 025, SA330 650 926 2102 025, A330 650 926 2102 027, SA330 650 937 2102 006、SA330 650 937 2102 008、SA330 650 937 2102 010, ET Files、V BLUE、MTF、TG6、TH6、TF4 etc, A490 201 974 2502 040, A490 650 922 3102 008, A330 650 922 2802 010, 02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type, 025 05, 070 05, A4906509262502045、A4906509262502050、A4906509262502055、A4906509262502060、A4906509262502070、A4906509262502080, A490 650 926 2502 030, A490 650 922 3102 010, A497 201 974 2102 035, A490 650 926 3102 140
Primary DI / UDI-DI
06942200940011, 06942200940035, 06942200940004, 06942200945528, 06942200949205, 06942200940028, 06942200965113, 06942200950539, 06942200962204, 06942200941681, 06942200947706, 06942200946938, 06942200942428, 06942200961023, 06942200946204, 06942200965571, 06942200941506, 06942200950461, 06942200962600, 06942200941476, 06942200965434, 06942200941780, 06942200961795, 06942200945948, 06942200940516, 06942200941278, 06942200949380, 06942200940578, 06942200962587, 06942200940097, 06942200962594, 06942200962495, 06942200962433, 06942200947621, 06942200946174, 06942200940585, 06942200962389, 06942200945986, 06942200960958, 06942200964543, 06942200962891, 06942200937684, 06942200951505, 06942200949403, 06942200926336, 06942200926411, 06942200944118, 06942200942985, 06942200951581, 06942200977703, 06942200968022
Basic UDI-DI
697590932SSTHandfilesJ4, 697590932NiTiRotary96, 69422009APPXM
EMDN Code
Q010507, Q01010401
Device Class
Class IIa
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanwei Perfect Medical Instruments Co., Ltd.

See all devices from Shanwei Perfect Medical Instruments Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No