ZZ BASE OS-US-ICSC 3.5 (Impression coping Screw)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- IMPRESSION COPING SCREW EUDAMEDZZ BASE OS-US-ICSC 3.5 (Impression coping Screw) FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Dental Resins Class I EUDAMEDCompatible with OSSTEM Implant US implants Consisting of: 1x Screw for impression copings FDA UDI
- Model / Reference
- BSFExx(x)yy EUDAMEDBSFE4301 FDA UDI
- Description
- Compatible with OSSTEM Implant US implants Consisting of: 1x Screw for impression copings FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800BSFExx(x)yy0 EUDAMEDD800BSFE4301 FDA UDI
- Basic UDI-DI
- ++D800IMPRCOP01CV EUDAMED
- Direct Marketing DI
- D800BSFExx(x)yy0 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, reusable
ZZ BASE OS-US-ICSC 3.5 (Impression coping Screw) by Zirkonzahn GmbH — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (2)
- FDA UDI 40955860-f17b-46c6-89cf-9ac17291757a 34 fields · synced Jul 16, 2026
- EUDAMED 5af5698c-5706-4687-a331-3a3c738f46fd 61 fields · synced Jul 16, 2026