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Crystal Bulk Polar White (1500 Tips)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CT2101
Identity
- Trade Name
- CRYSTAL BULK POLAR WHITE (1500 TIPS) EUDAMEDCrystal Tip FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece tip FDA UDI
- Device Name
- CRYSTAL BULK POLAR WHITE (1500 TIPS) EUDAMEDCRYSTAL BULK POLAR WHITE, TIPS FDA UDI
- Model / Reference
- CT2101 EUDAMEDFDA UDI
- Description
- CRYSTAL BULK POLAR WHITE, TIPS FDA UDI
Identifiers
- Catalog Number
- CT2101 FDA UDI
- Primary DI / UDI-DI
- 10843471132415 EUDAMED00843471132418 FDA UDI
- Basic UDI-DI
- B-10843471132415 EUDAMED
- FDA Product Code
- ECB FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental delivery system irrigation handpiece tip FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Crystal Bulk Polar White (1500 Tips) by Young Innovations, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10843471132415 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 10e65312-35ad-4464-b438-8fa51bcc1845 61 fields · synced Jun 18, 2026
- FDA UDI fe9484d2-725d-497f-984a-df3f3b52aca3 35 fields · synced May 30, 2026