Identity
- Trade Name
- MANI DIA-BURS - TC-26 EUDAMEDMANI DIA-BURS FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- MANI DIA-BURS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMEDTC-26 FDA UDI
- Description
- MANI DIA-BURS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951607593 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000018ZS EUDAMEDB-04546951607593 EUDAMED
- Unit of Use DI
- 74546951607592 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 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
Yes
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 Dia-Burs - Tc-26 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 | 4546951000018ZS | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 4546951000018ZS | 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 1ac2e761-0193-42e5-9b9e-fb797cb1ae32 61 fields · synced Jul 12, 2026
- EUDAMED 11689d73-3af8-4a69-b778-424a4f5ea1f0 61 fields · synced May 17, 2026
- FDA UDI 1f49b197-0dab-4659-8265-f73bb2cf9de7 33 fields · synced May 30, 2026