Identity
- Trade Name
- Black Brush #1 Bent EUDAMEDBrush Black #1 Bent FDA UDI
- Generic Name
- Dental-professional prophylaxis brush, reusable FDA UDI
- Device Name
- Black Brush EUDAMED
- Model / Reference
- 201211 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D7792012110 EUDAMEDD7792012111 FDA UDI
- Basic UDI-DI
- ++D779BRUSH101CD EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental-professional prophylaxis brush, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 FDA UDI
- Market of Registration
- Spain 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material injection cannula, single-use
Black Brush #1 Bent by Cosmedent, Inc. — 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 | ++D779BRUSH101CD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cosmedent, Inc.
- EUDAMED SRN
- US-MF-000045496
- Authorised Representative
- SAS Exclusivas Dentales S.L. ES-AR-000045423
Sources (2)
- EUDAMED 9a058459-a469-4f63-97bb-7a72a7e9082a 61 fields · synced Jul 16, 2026
- FDA UDI dca90c1b-8126-4f25-be4f-4094693a4452 32 fields · synced May 30, 2026