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New Ace

by Yamahachi Dental Mfg., Co. 190 variants

Ref 20PCS,L4,LL2,A4, 20PCS,O2,UL3,A3.5, 20PCS,T1,UR1,B2, 6*20CAN,S6,U,A2, 20PCS,L7,LR3,B2, 20PCS,T5,UR3,C2, 20PCS,TL7,UL2,C2, 20PCS,TL4,UL3,D3, 20PCS,L7,LL3,D3, 20PCS,S6,UL2,A2, 20PCS,S4,UR1,A4, 20PCS,L10,LR2,C4, 20PCS,L11,LL2,B1, 20PCS,O5,UL2,W0.5, 20PCS,T3,UL2,C2, 20PCS,TL5,UR2,A2, 20PCS,T2,UL3,C4, 20PCS,S8,UL2,A3.5, 20PCS,T4,UL1,B2, 6*1SET,L6,L,B2, 20PCS,T5,UR1,B1, 20PCS,TL7,UR3,A2, 20PCS,O5,UR3,C3, 20PCS,S2,UL1,A3, 20PCS,O4,UL3,A1, 20PCS,SS3,UL3,B2, 20PCS,T1,UL3,A1, 20PCS,T3,UR3,A3.5, 20PCS,S6,UL3,C2, 20PCS,L2,LL2,B3, 20PCS,S3,UR3,B2, 20PCS,T1,UR2,B2, 6*20CAN,S5,U,A3.5, 20PCS,S4,UL1,A4, 20PCS,T4,UR3,C2, 6*1SET,O4,U,B2, 20PCS,S5,UR1,A3.5, 20PCS,TL6,UL2,A1, 6*1SET,S6,U,B4, 6*20CAN,O2,U,B1, 6*20CAN,SS3,U,W0.5, 20PCS,S2,UR1,A1, 20PCS,T3,UL2,A2, 20PCS,TL5,UR1,A1, 6*1SET,S4,U,A4, 20PCS,S2,UL3,B1, 20PCS,T3,UL2,C1, 6*20CAN,L2,L,D4, 20PCS,T5,UR1,B2, 20PCS,S3,UR1,W0.5, 20PCS,O5,UL3,C4

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-PLNEWXXL4L2XA4 Basic UDI-DI Date26 Dec 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
20PCS, L4, LL2, A4, O2, UL3, A3.5, T1, UR1, B2, 6*20CAN, S6, U, A2, L7, LR3, T5, UR3, C2, TL7, UL2, TL4, D3, LL3, S4, L10, LR2, C4, L11, B1, O5, W0.5, T3, TL5, UR2, T2, S8, T4, UL1, 6*1SET, L6, L, C3, S2, A3, O4, A1, SS3, L2, B3, S3, S5, TL6, B4, C1, D4
Primary DI / UDI-DI
PLNEWXXL4L2XA4, PUNEWXXO2L3A35, PUNEWXXT1R1XB2, PCNEWXXS6XUXA2, PLNEWXXL7R3XB2, PUNEWXXT5R3XC2, PUNEWXTL7L2XC2, PUNEWXTL4L3XD3, PLNEWXXL7L3XD3, PUNEWXXS6L2XA2, PUNEWXXS4R1XA4, PLNEWXL10R2XC4, PLNEWXL11L2XB1, PUNEWXXO5L2W05, PUNEWXXT3L2XC2, PUNEWXTL5R2XA2, PUNEWXXT2L3XC4, PUNEWXXS8L2A35, PUNEWXXT4L1XB2, SSNEWXXL6XLXB2, PUNEWXXT5R1XB1, PUNEWXTL7R3XA2, PUNEWXXO5R3XC3, PUNEWXXS2L1XA3, PUNEWXXO4L3XA1, PUNEWXSS3L3XB2, PUNEWXXT1L3XA1, PUNEWXXT3R3A35, PUNEWXXS6L3XC2, PLNEWXXL2L2XB3, PUNEWXXS3R3XB2, PUNEWXXT1R2XB2, PCNEWXXS5XUA35, PUNEWXXS4L1XA4, PUNEWXXT4R3XC2, SSNEWXXO4XUXB2, PUNEWXXS5R1A35, PUNEWXTL6L2XA1, SSNEWXXS6XUXB4, PCNEWXXO2XUXB1, PCNEWXSS3XUW05, PUNEWXXS2R1XA1, PUNEWXXT3L2XA2, PUNEWXTL5R1XA1, SSNEWXXS4XUXA4, PUNEWXXS2L3XB1, PUNEWXXT3L2XC1, PCNEWXXL2XLXD4, PUNEWXXT5R1XB2, PUNEWXXS3R1W05, PUNEWXXO5L3XC4
Basic UDI-DI
B-PLNEWXXL4L2XA4, B-PUNEWXXO2L3A35, B-PUNEWXXT1R1XB2, B-PCNEWXXS6XUXA2, B-PLNEWXXL7R3XB2, B-PUNEWXXT5R3XC2, B-PUNEWXTL7L2XC2, B-PUNEWXTL4L3XD3, B-PLNEWXXL7L3XD3, B-PUNEWXXS6L2XA2, B-PUNEWXXS4R1XA4, B-PLNEWXL10R2XC4, B-PLNEWXL11L2XB1, B-PUNEWXXO5L2W05, B-PUNEWXXT3L2XC2, B-PUNEWXTL5R2XA2, B-PUNEWXXT2L3XC4, B-PUNEWXXS8L2A35, B-PUNEWXXT4L1XB2, B-SSNEWXXL6XLXB2, B-PUNEWXXT5R1XB1, B-PUNEWXTL7R3XA2, B-PUNEWXXO5R3XC3, B-PUNEWXXS2L1XA3, B-PUNEWXXO4L3XA1, B-PUNEWXSS3L3XB2, B-PUNEWXXT1L3XA1, B-PUNEWXXT3R3A35, B-PUNEWXXS6L3XC2, B-PLNEWXXL2L2XB3, B-PUNEWXXS3R3XB2, B-PUNEWXXT1R2XB2, B-PCNEWXXS5XUA35, B-PUNEWXXS4L1XA4, B-PUNEWXXT4R3XC2, B-SSNEWXXO4XUXB2, B-PUNEWXXS5R1A35, B-PUNEWXTL6L2XA1, B-SSNEWXXS6XUXB4, B-PCNEWXXO2XUXB1, B-PCNEWXSS3XUW05, B-PUNEWXXS2R1XA1, B-PUNEWXXT3L2XA2, B-PUNEWXTL5R1XA1, B-SSNEWXXS4XUXA4, B-PUNEWXXS2L3XB1, B-PUNEWXXT3L2XC1, B-PCNEWXXL2XLXD4, B-PUNEWXXT5R1XB2, B-PUNEWXXS3R1W05, B-PUNEWXXO5L3XC4
EMDN Code
Q01020601 Mobile dental prostheses
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: Partial denture

Similar devices

Also classified as Partial denture.

Other devices from Yamahachi Dental Mfg., Co.

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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