Identity
- Trade Name
- DIAMOND BUR 3097C - Box with 10 EUDAMEDDIAMOND BUR 3097 - Box with 10 EUDAMED
- Device Name
- DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- Model / Reference
- 3097C EUDAMED3097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07908516806143 EUDAMED07898229801194 EUDAMED
- Basic UDI-DI
- 79085168diamondbursD6 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
DIAMOND BUR 3097C - Box with 10 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.
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- SSW CARBIDE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
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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 | 79085168diamondbursD6 | 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 (2)
- EUDAMED ed21519b-d979-4111-bceb-fe74acc3420d 61 fields · synced Jul 24, 2026
- EUDAMED 62b0e2fd-ab6d-4d6e-bfad-0a39855296f4 61 fields · synced May 19, 2026