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Dental Burs

by Shenzhen Americuras Co., Ltd 312 variants

Part of a family of 312 devices: see the family page

Ref SI-46SCModel FG1-FG-1/4、FG1-FG-1/2、FG1-FG-1、 FG1-FG-2、FG1-FG-3、FG1-FG-4、 FG1-FG-5、FG1-FG-6、FG1-FG-7、 FG1-FG-8、FG1-RA-1/2、FG1-RA-1、 FG1-RA-2、FG1-RA-3、FG1-RA-4、 FG1-RA-5、FG1-RA-6、FG1-RA-7、etc

Dental Burs (SI-46SC) is a Class I device made by Shenzhen Americuras Co., Ltd, registered in EUDAMED on 26 Jan 2026 (Basic UDI-DI 697820314DBYR), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697820314DBYR Basic UDI-DI 06978203147317UDI-DIDate26 Jan 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Dental Burs
Model / reference
FG1-FG-1/4、FG1-FG-1/2、FG1-FG-1、 FG1-FG-2、FG1-FG-3、FG1-FG-4、 FG1-FG-5、FG1-FG-6、FG1-FG-7、 FG1-FG-8、FG1-RA-1/2、FG1-RA-1、 FG1-RA-2、FG1-RA-3、FG1-RA-4、 FG1-RA-5、FG1-RA-6、FG1-RA-7、etc, SI-46SC
Primary DI / UDI-DI
06978203147317
Basic UDI-DI
697820314DBYR
EMDN code
Q010501 Dental burs and abrasive disks, single-use
Device class
Class I
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048352
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Carbide dental bur, single-use

Similar devices in this category

Other devices filed under DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE.

Other devices from Shenzhen Americuras Co., Ltd

See all devices from Shenzhen Americuras Co., Ltd →

Properties

  • Sterilise before use
Other properties (13, all answered No)