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Abro Basic Multistratum A2-A3 98H28 with step
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref DSCLxx(x)yy(ww)(zzz(z))
Identity
- Trade Name
- ABRO BASIC MULTISTRATUM EUDAMEDAbro Basic Multistratum A2-A3 98H28 with step FDA UDI
- Generic Name
- Dental bridge, polymer FDA UDI
- Device Name
- Dental Resins EUDAMEDContent: 1 piece Height: 28 mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. Specifically designed for the production of denture teeth, long-term temporaries as well as secondary and tertiary structures. FDA UDI
- Model / Reference
- DSCLxx(x)yy(ww)(zzz(z)) EUDAMEDDSCL98S28A2A3 FDA UDI
- Description
- Content: 1 piece Height: 28 mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. Specifically designed for the production of denture teeth, long-term temporaries as well as secondary and tertiary structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800DSCLxx(x)yy(ww)(zzz(z))0 EUDAMEDD800DSCL98S28A2A30 FDA UDI
- Basic UDI-DI
- ++D800RES002001HJ EUDAMED
- Direct Marketing DI
- D800DSCLxx(x)yy(ww)(zzz(z))0 EUDAMED
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMED
- GMDN Term
- Dental bridge, polymer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bridge, polymer
Abro Basic Multistratum A2-A3 98H28 with step 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
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 (2)
- FDA UDI 420ee471-0438-48fc-9154-2bc8ef3f449d 34 fields · synced Jul 30, 2026
- EUDAMED dbdb9b84-97f3-44db-b387-c6e8fd59b958 61 fields · synced Jul 30, 2026