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Re-Fine Bright

by Yamahachi Dental Mfg., Co. 54 variants

Ref 15G*20ML,CLEAR PINK, 15G,CLEAR PINK, 250G,D2, 15G*20ML,MARBLE H, 250G,O PINK, 15G,PINK, 10KG,A3.5, 250G,B1, 250G*260ML,A4, 15G*20ML,LF α, 250G*260ML,B1, 250G,LF α, 10KG,LF PINK, 10KG,A1, 15G,B3, 15G,O PINK, 15G,V PINK, 250G,C4, 10KG,B4, 250G*260ML,LF PINK, 15G*20ML,LF PINK, 15G,A3, 250G,C2, 250G*260ML,B2, 15G*20ML,B3, 15G*20ML,W0.5, 250G*260ML,D2, 10KG,C1, 15G*20ML,PINK, 250G*260ML,C2, 250G*260ML,C1, 15G*20ML,D2, 15G*20ML,C3, 250G*260ML,MARBLE PINK, 15G,LF α, 250G*260ML,A3.5, 15G*20ML,C4, 10KG,INCISAL, 15G,C3, 250G,CLEAR PINK, 250G*260ML,A1, 250G,V PINK, 10KG,A2, 10KG,V PINK, 250G,A3, 250G*260ML,A2, 250G*260ML,O PINK, 250G*260ML,W0.5, 10KG,W0.5, 15G,A1, 10KG,LF α

Active European Union

CE MDR CE MDD

Valid until

12 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberJP26/00000198 Date31 Jul 2026IssuedStatusActive expires 12 Jun 2031
European UnionCE/MDD NumberB-XXRFB15G2XXCLP Basic UDI-DI Date7 Jan 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP26/00000198 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    31 Jul 2026
    Expires
    12 Jun 2031
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
15G*20ML, CLEAR PINK, 15G, 250G, D2, MARBLE H, O PINK, PINK, 10KG, A3.5, B1, 250G*260ML, A4, LF α, LF PINK, A1, B3, V PINK, C4, B4, A3, C2, B2, W0.5, C1, C3, MARBLE PINK, INCISAL, A2
Primary DI / UDI-DI
XXRFB15G2XXCLP, XXRFBX15GXXCLP, XXRFB250GXXXD2, XXRFB15G2XXMBH, XXRFB250GXXOPN, XXRFBX15GXXPNK, XXRFB10KGXXA35, XXRFB250GXXXB1, XXRFB2526XXXA4, XXRFB15G2XXLFA, XXRFB2526XXXB1, XXRFB250GXXLFA, XXRFB10KGXXLFP, XXRFB10KGXXXA1, XXRFBX15GXXXB3, XXRFBX15GXXOPN, XXRFBX15GXXVPN, XXRFB250GXXXC4, XXRFB10KGXXXB4, XXRFB2526XXLFP, XXRFB15G2XXLFP, XXRFBX15GXXXA3, XXRFB250GXXXC2, XXRFB2526XXXB2, XXRFB15G2XXXB3, XXRFB15G2XXW05, XXRFB2526XXXD2, XXRFB10KGXXXC1, XXRFB15G2XXPNK, XXRFB2526XXXC2, XXRFB2526XXXC1, XXRFB15G2XXXD2, XXRFB15G2XXXC3, XXRFB2526XXMBP, XXRFBX15GXXLFA, XXRFB2526XXA35, XXRFB15G2XXXC4, XXRFB10KGXXINC, XXRFBX15GXXXC3, XXRFB250GXXCLP, XXRFB2526XXXA1, XXRFB250GXXVPN, XXRFB10KGXXXA2, XXRFB10KGXXVPN, XXRFB250GXXXA3, XXRFB2526XXXA2, XXRFB2526XXOPN, XXRFB2526XXW05, XXRFB10KGXXW05, XXRFBX15GXXXA1, XXRFB10KGXXLFA
Basic UDI-DI
B-XXRFB15G2XXCLP, B-XXRFBX15GXXCLP, B-XXRFB250GXXXD2, B-XXRFB15G2XXMBH, B-XXRFB250GXXOPN, B-XXRFBX15GXXPNK, B-XXRFB10KGXXA35, B-XXRFB250GXXXB1, B-XXRFB2526XXXA4, B-XXRFB15G2XXLFA, B-XXRFB2526XXXB1, B-XXRFB250GXXLFA, B-XXRFB10KGXXLFP, B-XXRFB10KGXXXA1, B-XXRFBX15GXXXB3, B-XXRFBX15GXXOPN, B-XXRFBX15GXXVPN, B-XXRFB250GXXXC4, B-XXRFB10KGXXXB4, B-XXRFB2526XXLFP, B-XXRFB15G2XXLFP, B-XXRFBX15GXXXA3, B-XXRFB250GXXXC2, B-XXRFB2526XXXB2, B-XXRFB15G2XXXB3, B-XXRFB15G2XXW05, B-XXRFB2526XXXD2, B-XXRFB10KGXXXC1, B-XXRFB15G2XXPNK, B-XXRFB2526XXXC2, B-XXRFB2526XXXC1, B-XXRFB15G2XXXD2, B-XXRFB15G2XXXC3, B-XXRFB2526XXMBP, B-XXRFBX15GXXLFA, B-XXRFB2526XXA35, B-XXRFB15G2XXXC4, B-XXRFB10KGXXINC, B-XXRFBX15GXXXC3, B-XXRFB250GXXCLP, B-XXRFB2526XXXA1, B-XXRFB250GXXVPN, B-XXRFB10KGXXXA2, B-XXRFB10KGXXVPN, B-XXRFB250GXXXA3, B-XXRFB2526XXXA2, B-XXRFB2526XXOPN, B-XXRFB2526XXW05, B-XXRFB10KGXXW05, B-XXRFBX15GXXXA1, B-XXRFB10KGXXLFA
EMDN Code
Q0102050101 Temporary teeth resins
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Dental appliance fabrication material, resin

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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