Identity
- Trade Name
- Young Dental FDA UDI
- Generic Name
- Dental caries detecting stain FDA UDI
- Device Name
- PLK SMACK 2 TONE TAB 250CT FDA UDI
- Model / Reference
- 243225 FDA UDI
- Description
- PLK SMACK 2 TONE TAB 250CT FDA UDI
Identifiers
- Catalog Number
- 243225 FDA UDI
- Primary DI / UDI-DI
- 00840326405949 FDA UDI
- FDA Product Code
- QJC FDA UDI
- GMDN Term
- Dental caries detecting stain FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 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
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
Category: Dental caries detecting stain
Young Dental by Young Dental Manufacturing I, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental caries detecting stain.
- Expose — CENTRIX, INC. · Class II
- Vista Blue Fracture Detection Kit — Vista Dental · Class II
- IQ Dental — IQ DENTAL SUPPLY LLC · Class II
- IQ Dental — IQ DENTAL SUPPLY LLC · Class II
- Vista-Green Unit Dose — Vista Dental · Class II
- BlueCheck — Incisive Technologies Pty, Ltd. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Expose — CENTRIX, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Young Dental Manufacturing I, Llc
Sources (1)
- FDA UDI 461599d1-5f1b-4040-b0aa-7331304a587a 35 fields · synced Jun 8, 2026