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2-tone disclosing tablets bulk
EUDAMEDFDA UDIClass I (EU MDR)
Ref 234200Model Plaque Dislcosing Products
Identity
- Trade Name
- 2-tone disclosing tablets bulk EUDAMEDYoung Dental FDA UDI
- Generic Name
- Dental caries detecting stain FDA UDI
- Device Name
- 2-TONE DISC TAB BULK FDA UDI
- Model / Reference
- Plaque Dislcosing Products EUDAMED234200 EUDAMEDFDA UDI
- Description
- 2-TONE DISC TAB BULK FDA UDI
Identifiers
- Catalog Number
- 234200 FDA UDI
- Primary DI / UDI-DI
- 10302732342005 EUDAMED00302732342008 FDA UDI
- Basic UDI-DI
- 03027360408D530780QJCSZ EUDAMED
- FDA Product Code
- QJC FDA UDI
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
- GMDN Term
- Dental caries detecting stain FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6855 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
2-tone disclosing tablets bulk by Young Dental Manufacturing I, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 03027360408D530780QJCSZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Dental Manufacturing I, LLC
- EUDAMED SRN
- US-MF-000027132
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 8a852539-efb2-4002-b5e1-ab621c897a3f 61 fields · synced Oct 6, 2026
- FDA UDI 2b160a5f-0bbf-47cd-97ca-9f13ab188a4c 35 fields · synced May 30, 2026