FDA UDI
In Commercial Distribution
🇺🇸 United States
Young Dental
DI: 00302732342251
·
Model: 234225
·
YOUNG DENTAL MANUFACTURING I, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Young Dental
- Primary DI
- 00302732342251
- Version / Model
- 234225
- Catalog Number
- 234225
- Company Name
- YOUNG DENTAL MANUFACTURING I, LLC
- Labeler DUNS
- 006309355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-17
- Public Version
- 2
- Public Version Date
- 2025-08-12
- Public Version Status
- Update
- Public Device Record Key
- 38813234-3d61-4004-a420-c1db242ed106
Device Description
2 TONE DISCL TABLET 250 COUNT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QJC | Plaque Disclosing Agent | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60408 | Dental caries detecting stain | A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10302732342258 | GS1 | 250 | In Commercial Distribution | ||
| Primary | 00302732342251 | GS1 | ||||
| Package | 20302732342255 | GS1 | Case | 60 | In Commercial Distribution |
Customer Contacts
- Phone
- (800) 325-1881
- [email protected]