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Plak Smacker Relief Wax - Mint Scented (144 ct)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10459
Identity
- Trade Name
- Plak Smacker Relief Wax - Mint Scented (144 ct) EUDAMEDPlak Smacker FDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- Plak Smacker Relief Wax - Mint Scented (144 ct) EUDAMEDPLAK SMACKER MINT WAX (144 ct) FDA UDI
- Model / Reference
- 10459 EUDAMEDFDA UDI
- Description
- PLAK SMACKER MINT WAX (144 ct) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843471137588 EUDAMED00843471137581 FDA UDI
- Basic UDI-DI
- 0843471145251EGDD409984NG EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Plak Smacker Relief Wax - Mint Scented (144 ct) by Young Innovations, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0843471145251EGDD409984NG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 d8547a32-b6e6-4c4c-b5c1-8c19450dea20 61 fields · synced Jun 18, 2026
- FDA UDI 3d2308aa-ff15-469d-bf0f-6ea028c2d9e3 34 fields · synced May 30, 2026