Identity
- Trade Name
- GUM® FDA UDI
- Generic Name
- Periodontal pick/brush, reusable FDA UDI
- Device Name
- US Professional Dental Sample Kit comprised of 1 x 525PHS Deep Clean Technique Toothbrush 1x 2030PQA Expanding Floss 1 x 828PQ Twisted Mint Flosser 1 x 872PQ Proxabrush Tight Interdental Brush 1 x 3612PQ Proxabrush Moderate Interdental Brush 1 x 650PA Soft Pick Advanced Interdental Pick 1 x 308PD End Tuft Toothbrush 1 x 600PYC Rubber Tip Stimulator 1 x 760PB Tongue Cleaner /Scraper 1 x 895 PQ Crayola Kids Flosser 1 x 227A Crayola Marker Toothbrush FDA UDI
- Model / Reference
- KIT59 FDA UDI
- Description
- US Professional Dental Sample Kit comprised of 1 x 525PHS Deep Clean Technique Toothbrush 1x 2030PQA Expanding Floss 1 x 828PQ Twisted Mint Flosser 1 x 872PQ Proxabrush Tight Interdental Brush 1 x 3612PQ Proxabrush Moderate Interdental Brush 1 x 650PA Soft Pick Advanced Interdental Pick 1 x 308PD End Tuft Toothbrush 1 x 600PYC Rubber Tip Stimulator 1 x 760PB Tongue Cleaner /Scraper 1 x 895 PQ Crayola Kids Flosser 1 x 227A Crayola Marker Toothbrush FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070942007849 FDA UDI
- FDA Product Code
- JES FDA UDIEFW FDA UDIJET FDA UDILCN FDA UDI
- GMDN Term
- Periodontal pick/brush, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6390 FDA UDI872.6855 FDA UDI872.6650 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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 flossBasic manual toothbrushPeriodontal pick/brush, reusableTongue scraper, reusable
Gum® by Sunstar Americas, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- Chocolate Kids Tongue Scraper Double Scoops — Supermouth LLC · 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
- Sunstar Americas, Inc.
Sources (1)
- FDA UDI ddaae650-a939-4e38-8050-887fe26c4ac8 33 fields · synced Jun 1, 2026