Multi Angled Abutment Carrier, Regular
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Dental Implantation Instruments EUDAMEDMulti Angled Abutment Carrier,Regular FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Dental Implantation Instruments EUDAMED
- Model / Reference
- 069476003000803F8 EUDAMED353050U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600317876 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003000803F8 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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: Manual non-rotary dental instrument handle
Multi Angled Abutment Carrier, Regular by BIO CONCEPT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual non-rotary dental instrument handle.
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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
- BIO CONCEPT Co., Ltd.
Sources (2)
- FDA UDI 2913360a-c323-4185-9182-7faeba489461 32 fields · synced Aug 2, 2026
- EUDAMED 7564e1cf-3e2c-4686-af06-071317990b53 61 fields · synced Aug 2, 2026