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Prettau® 4 Anterior® Dispersive® C3 3
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ZROFxxxxyyyRef ZRODxxxx
Identity
- Trade Name
- PRETTAU 3 ANTERIOR DISPERSIVE EUDAMEDPRETTAU 3 ANTERIOR EUDAMEDPrettau® 4 Anterior® Dispersive® C3 3 FDA UDI
- Generic Name
- Dental bridge, ceramic FDA UDI
- Device Name
- Dental Zirconia Blanks EUDAMEDContent: 1 piece, Height: 16 mm, Polychromatic, pre-coloured zirconia with natural multicolour shading for the manufacture of single crowns, inlays, onlays, veneers as well as 3-unit bridges (full contour restorations or reduced structures for ceramic layering) FDA UDI
- Model / Reference
- ZROFxxxxyyy EUDAMEDZRODxxxx EUDAMEDZRFC0201C03 FDA UDI
- Description
- Content: 1 piece, Height: 16 mm, Polychromatic, pre-coloured zirconia with natural multicolour shading for the manufacture of single crowns, inlays, onlays, veneers as well as 3-unit bridges (full contour restorations or reduced structures for ceramic layering) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800ZROFxxxxyyy0 EUDAMEDD800ZRODxxxx0 EUDAMEDD800ZRFC0201C03 FDA UDI
- Basic UDI-DI
- ++D800ZR004001G3 EUDAMED
- Direct Marketing DI
- D800ZROFxxxxyyy0 EUDAMEDD800ZRODxxxx0 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01020602 COMBINED DENTAL PROSTHESES EUDAMED
- GMDN Term
- Dental bridge, 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bridge, ceramic
Prettau® 4 Anterior® Dispersive® C3 3 by Zirkonzahn GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental bridge, ceramic.
- Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs — Institut Straumann SA · Class II
- Zerion Alpha, Zerion Beta — Institut Straumann SA · Class II
- Zerion Alpha, Zerion Beta — Institut Straumann SA · Class II
- Zerion Alpha, Zerion Beta — Institut Straumann SA · Class II
- Prodent — Prodent Dental Technology (Shenzhen) Co., Ltd. · Class II
- Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- KATANA Zirconia — Institut Straumann SA · Class II
- ATLANTIS™ — DENTSPLY IH, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (3)
- FDA UDI dd79424d-1958-499c-84c1-dc7d6fb1de23 34 fields · synced Jul 10, 2026
- EUDAMED fca01ae5-815c-4084-a1e7-c893ba886996 61 fields · synced Jul 8, 2026
- EUDAMED 52bc9bdc-c301-4079-b69a-1e3bbad09fb5 61 fields · synced Jul 10, 2026