Identity
- Trade Name
- Plak Smacker FDA UDI
- Generic Name
- Dental floss FDA UDI
- Device Name
- Imprinted Ortho Water Bottle Kit (BPA Free) FDA UDI
- Model / Reference
- 12021IMP FDA UDI
- Description
- Imprinted Ortho Water Bottle Kit (BPA Free) FDA UDI
Identifiers
- Catalog Number
- 12021IMP FDA UDI
- Primary DI / UDI-DI
- 00840326411858 FDA UDI
- FDA Product Code
- JES FDA UDI
- GMDN Term
- Dental floss FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
Category: Dental floss
The Plak Smacker is a dental floss designed for the removal of plaque and/or debris from teeth and fixed prostheses. Made of synthetic fibre, it cannot be reused after application.
Similar devices
Also classified as Dental floss.
- GUM® — SUNSTAR AMERICAS, INC. · Class I
- 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- H.E.B — H. E. BUTT GROCERY COMPANY · Class I
- Freshmint — NEW WORLD IMPORTS, INC. · Class I
- PRO-SYS — BENCO DENTAL SUPPLY CO. · Class I
- GUM — SUNSTAR AMERICAS, INC. · Class I
- GUM® — SUNSTAR AMERICAS, INC. · Class I
- Up&Up — TARGET CORPORATION · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI 489c99de-8397-414a-8644-af92bba4f8e0 35 fields · synced Jul 22, 2026