Identity
- Trade Name
- MANI CARBIDE BURS - 16DB EUDAMEDMANI CARBIDE BURS FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- MANI CARBIDE BURS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED16DB FDA UDI
- Description
- MANI CARBIDE BURS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951534615 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951534615 EUDAMED4546951000017ZQ EUDAMED
- Unit of Use DI
- 74546951534614 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mani Carbide Burs - 16db by Mani, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951534615 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951534615 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 40cadd11-1971-4829-9ad5-f0ac00505493 61 fields · synced Jul 31, 2026
- EUDAMED 40f1ac4c-dbb1-49de-82cb-b63e6f7ef899 61 fields · synced May 19, 2026
- FDA UDI 82be22c6-daa0-4bbb-b5ff-7b02e6518c28 33 fields · synced May 30, 2026