Dental Zirconia Block
by Shenzhen Yurucheng Dental Materials Co., Ltd. FDA registration: China EUDAMEDGUDID
Ref 16187Model Color BL1-HT 98×12, Multilayer ML-0M2-3DPlus 98×35, Color C4-ST 89×71×20, Multilayer ML-B1-UT 95×22, Color 0M1-UT 95×16, Multilayer ML-0M3-UT 95×14, Color 0M3-SHT 98×20, Multilayer ML-A3.5-4D 95×10, Multilayer ML-0M2-SHT 98×12, Color OM1-ST 89×71×10, Color B2-HT 95×10, Color 0M1-UT 98×16, Color 0M1-SHT 89×71×18, Multilayer ML-BL3-SHT 98×14, Color D3-ST 95×16, Multilayer ML-B1-4D 98×35, Color B4-ST 95×25, Multilayer ML-0M1-SHT 98×25, Color C2-SHT 89×71×25, Multilayer ML-BL3-ST 98×18, Color D2-ST 98×18, Color B3-HT 95×14, Multilayer ML-B3-UT 95×14, Multilayer ML-A2-UT 95×25, Color C1-UT 98×30 Product code PKJEMDN Q010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06974242687517 | Date21 Aug 2023 | StatusListed |
| European Union | CE/MDD EUDAMED | NumberB-06974242687517 | Date5 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Dental Zirconia Block EUDAMEDYucera GUDID
- Generic Name
- Dental appliance fabrication material, ceramic
- Device Name
- Zirconia Dental Ceramics
- Model / Ref / Catalog
- Color BL1-HT 98×12 EUDAMED16187 EUDAMEDMultilayer ML-0M2-3DPlus 98×35 EUDAMEDColor C4-ST 89×71×20 EUDAMEDMultilayer ML-B1-UT 95×22 EUDAMEDColor 0M1-UT 95×16 EUDAMEDMultilayer ML-0M3-UT 95×14 EUDAMEDColor 0M3-SHT 98×20 EUDAMEDMultilayer ML-A3.5-4D 95×10 EUDAMEDMultilayer ML-0M2-SHT 98×12 EUDAMEDColor OM1-ST 89×71×10 EUDAMEDColor B2-HT 95×10 EUDAMEDColor 0M1-UT 98×16 EUDAMEDColor 0M1-SHT 89×71×18 EUDAMEDMultilayer ML-BL3-SHT 98×14 EUDAMEDColor D3-ST 95×16 EUDAMEDMultilayer ML-B1-4D 98×35 EUDAMEDColor B4-ST 95×25 EUDAMEDMultilayer ML-0M1-SHT 98×25 EUDAMEDColor C2-SHT 89×71×25 EUDAMEDMultilayer ML-BL3-ST 98×18 EUDAMEDColor D2-ST 98×18 EUDAMEDColor B3-HT 95×14 EUDAMEDMultilayer ML-B3-UT 95×14 EUDAMEDMultilayer ML-A2-UT 95×25 EUDAMEDColor C1-UT 98×30 EUDAMEDML-BL3-ST GUDIDML-0M2-3D GUDIDML-B1-UT GUDIDB3 GUDIDML-B1-4D GUDID0M1 GUDIDBL1 GUDIDML-A2-UT GUDIDC4 GUDIDB2 GUDIDC2 GUDIDML-BL3-SHT GUDID0M3 GUDIDD2 GUDIDML-0M2-SHT GUDIDML-B3-UT GUDIDML-0M1-SHT GUDIDC1 GUDIDML-0M3-UT GUDIDML-A3.5-4D GUDIDB4 GUDIDD3 GUDIDST 98×18mm GUDID3DPlus 98×35mm GUDIDUT 95×22mm GUDIDHT 95×14mm GUDID4D 98×35mm GUDIDUT 95×16mm GUDIDHT 98×12mm GUDIDUT 95×25mm GUDIDUT 98×16mm GUDIDST 89×71×20mm GUDIDHT 95×10mm GUDIDSHT 89×71×25mm GUDIDSHT 98×14mm GUDIDSHT 98×20mm GUDIDST 89×71×10mm GUDIDSHT 98×12mm GUDIDUT 95×14mm GUDIDSHT 89×71×18mm GUDIDSHT 98×25mm GUDIDUT 98×30mm GUDID4D 95×10mm GUDIDST 95×25mm GUDIDST 95×16mm GUDID
- Primary DI / UDI-DI
- 06974242687517, 06942053523102, 06942053527902, 06942053530728, 06974242685377, 06942053542158, 06942053510447, 06942053529739, 06942053510348, 06942053503791, 06974242685100, 06942053514810, 06942053540338, 06942053516616, 06942053504743, 06942053503852, 06942053539325, 06942053531183, 06942053516289, 06942053539134, 06942053508642, 06942053533934, 06942053541663, 06942053502732, 06942053504194
- Basic UDI-DI
- B-06974242687517, B-06942053527902, B-06942053503791, B-06942053530728, B-06942053510447, B-06942053533934, B-06942053516616, B-06942053541663, B-06942053539325, B-06942053504743, B-06974242685100, B-06942053510348, B-06942053516289, B-06942053540338, B-06942053504194, B-06942053542158, B-06942053502732, B-06942053539134, B-06942053514810, B-06942053523102, B-06942053503852, B-06974242685377, B-06942053531183, B-06942053529739, B-06942053508642
- FDA Product Code
- PKJ
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- GMDN Term
- Dental appliance fabrication material, ceramic
- Device Class
- Class IIa EUDAMEDN GUDID
- Market of Registration
- Türkiye
- Commercial Distribution
- Not in Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Color BL1-HT 98×12 16187 Multilayer ML-0M2-3DPlus 98×35 Color C4-ST 89×71×20 Multilayer ML-B1-UT 95×22 Color 0M1-UT 95×16 Multilayer ML-0M3-UT 95×14 Color 0M3-SHT 98×20 Multilayer ML-A3.5-4D 95×10 Multilayer ML-0M2-SHT 98×12 Color OM1-ST 89×71×10 Color B2-HT 95×10 Color 0M1-UT 98×16 Color 0M1-SHT 89×71×18 Multilayer ML-BL3-SHT 98×14 Color D3-ST 95×16 Multilayer ML-B1-4D 98×35 Color B4-ST 95×25 Multilayer ML-0M1-SHT 98×25 Color C2-SHT 89×71×25 Multilayer ML-BL3-ST 98×18 Color D2-ST 98×18 Color B3-HT 95×14 Multilayer ML-B3-UT 95×14 Multilayer ML-A2-UT 95×25 Color C1-UT 98×30 | ML-BL3-ST ML-0M2-3D ML-B1-UT B3 ML-B1-4D 0M1 BL1 ML-A2-UT C4 B2 C2 ML-BL3-SHT 0M3 D2 ML-0M2-SHT ML-B3-UT ML-0M1-SHT C1 ML-0M3-UT ML-A3.5-4D B4 D3 |
| Device Class | Class IIa | N |
| Implantable | Yes | No |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011505
- Authorised representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
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Properties & raw data
Show properties, registry sources and raw records
Other properties (16)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
Sources (50)
- EUDAMED 6d0ab583-18df-46aa-8a46-6dfaac5d3bd0
- FDA UDI a7438291-b76a-4672-acd1-48a99530c578
- FDA UDI b225280a-4c69-48e7-944a-0d8d58533580
- FDA UDI d3ca224a-99df-4a94-8930-8283e904816d
- FDA UDI 9fa180db-7d93-4689-ae97-a820f31699c4
- FDA UDI 53f98ac2-ea7a-4a66-8699-f5694e9fff47
- FDA UDI 3c91c2d9-caf5-4ea9-86a4-ff6cbd2a85fc
- FDA UDI cdf19747-70b8-46f4-b41b-b68350e375ae
- FDA UDI ff36ead2-ffcc-411b-849e-66d149c6222b
- FDA UDI dfab1a83-eb4c-425f-9175-ecf3e878fd13
- FDA UDI c61cac59-d24e-4ffb-8a8a-bc1f48258010
- FDA UDI 46953487-d29b-4b27-9dd0-d71952c274aa
- FDA UDI 70e7f3db-9c30-441e-afbb-d1f54b0750f2
- FDA UDI 9b7db5a7-ce81-4d3e-830c-61a8ea0db786
- FDA UDI f59ae0cb-c121-4125-bbc9-4875bd4f49d3
- FDA UDI 9237f644-cd99-47d0-ab2f-f977dabbeafc
- FDA UDI 0993a9c6-3515-4c4c-bd1d-cffe4739e7b3
- FDA UDI fe071dc3-4096-4298-b50a-eeafb805786f
- FDA UDI 6387e904-43f9-486e-852c-cd4b16c9b131
- FDA UDI 8762227c-dc10-4499-8bde-d8086fd55aec
- FDA UDI 416d5be0-b8c5-463e-b7bc-2f293b8d4f6c
- FDA UDI b4463b0f-a9c2-4094-8cc9-82dcf86d4b17
- FDA UDI 52bcd422-7b6b-4912-a3c7-adcce3f35fe7
- FDA UDI 273627c4-d6b7-4d55-919a-df522ec2489b
- FDA UDI 3dacb6c1-dbf0-47a2-b6cb-37ba0632e355
- FDA UDI 7d22e8a4-2839-47a7-abca-f2c010ba60c8
- EUDAMED 06942053527902|B-06942053527902
- EUDAMED 06942053503791|B-06942053503791
- EUDAMED 06942053530728|B-06942053530728
- EUDAMED 06942053510447|B-06942053510447
- EUDAMED 06942053533934|B-06942053533934
- EUDAMED 06942053516616|B-06942053516616
- EUDAMED 06942053541663|B-06942053541663
- EUDAMED 06942053539325|B-06942053539325
- EUDAMED 06942053504743|B-06942053504743
- EUDAMED 06974242685100|B-06974242685100
- EUDAMED 06942053510348|B-06942053510348
- EUDAMED 06942053516289|B-06942053516289
- EUDAMED 06942053540338|B-06942053540338
- EUDAMED 06942053504194|B-06942053504194
- EUDAMED 06942053542158|B-06942053542158
- EUDAMED 06942053502732|B-06942053502732
- EUDAMED 06942053539134|B-06942053539134
- EUDAMED 06942053514810|B-06942053514810
- EUDAMED 06942053523102|B-06942053523102
- EUDAMED 06942053503852|B-06942053503852
- EUDAMED 06974242685377|B-06974242685377
- EUDAMED 06942053531183|B-06942053531183
- EUDAMED 06942053529739|B-06942053529739
- EUDAMED 06942053508642|B-06942053508642