Identity
- Trade Name
- POLIDONT COMPLETE KIT EUDAMED
- Device Name
- DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- Model / Reference
- 10.810.001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898229805420 EUDAMED
- Basic UDI-DI
- 79085168polidontP2 EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Carbide dental bur, single-use
Polidont Complete Kit by 3R Indústria E Comércio LTDA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, single-use.
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- SSW CARBIDE GREAT WHITE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- MAXCUT CARBIDE BUR (10/pk) FG 171 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 79085168polidontP2 | Class I | Active |
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Manufacturer
- Manufacturer
- 3R Indústria E Comércio LTDA
- EUDAMED SRN
- BR-MF-000034808
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (1)
- EUDAMED f9e44f39-49ae-46c5-ae86-3bad32ff19b0 61 fields · synced Jun 19, 2026