Blackstone 2 Artistic A3, 5 106H12
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BLACKSTONE 5 EUDAMEDBlackstone 2 Artistic A3,5 106H12 FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Dental Zirconia Blanks EUDAMEDContent: 1 piece Height: 12 mm FDA UDI
- Model / Reference
- ZRLRxxxxyyy EUDAMEDZRLF4012A35 FDA UDI
- Description
- Content: 1 piece Height: 12 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800ZRLRxxxxyyy0 EUDAMEDD800ZRLF4012A35 FDA UDI
- Basic UDI-DI
- ++D800ZR010001FJ EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01020602 COMBINED DENTAL PROSTHESES EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
Blackstone 2 Artistic A3, 5 106H12 by Zirkonzahn GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (2)
- FDA UDI 5855c146-a021-4f11-ba2c-6b8933c4119f 34 fields · synced Jul 25, 2026
- EUDAMED 17ed2748-93ac-4cab-bb76-50b330ab11ee 61 fields · synced Jul 25, 2026