Identity
- Trade Name
- DCI Edge FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Unit, Operative Dental EUDAMEDDCI Edge Over the Patient Auto Dental Unit Series 4 FDA UDI
- Model / Reference
- Dental Units EUDAMEDDO4 FDA UDI
- Description
- DCI Edge Over the Patient Auto Dental Unit Series 4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810021432175 EUDAMEDFDA UDI
- Basic UDI-DI
- 081002143UNIT2J EUDAMED
- Direct Marketing DI
- 00810021432175 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system
Unit, Operative Dental by DCI International, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081002143UNIT2J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DCI International, LLC
- EUDAMED SRN
- US-MF-000022306
- Authorised Representative
- DENTAL COMPONENTS EUROPE FR-AR-000013263
Sources (2)
- EUDAMED 7fc0d081-9263-47f9-a1bb-46665bda68a4 61 fields · synced Jun 9, 2026
- FDA UDI 0e16fe04-3432-410c-aea7-0c5f8606b5e4 34 fields · synced May 25, 2026