Identity
- Trade Name
- Young FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Zooby Varnish, 5% Sodium Fluoride White Varnish, Assorted Flavors, Sample Pack - 3ct FDA UDI
- Model / Reference
- 999304 FDA UDI
- Description
- Zooby Varnish, 5% Sodium Fluoride White Varnish, Assorted Flavors, Sample Pack - 3ct FDA UDI
Identifiers
- Catalog Number
- 999304 FDA UDI
- Primary DI / UDI-DI
- 00302730002409 FDA UDI
- 510(k) Number
- K080814 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental coating, tooth-desensitizing, professional
Young by Young Dental Manufacturing I, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080814 also covers:
- ProGaurd™ — HU-FRIEDY MFG CO., LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
- D-LISH — YOUNG DENTAL MANUFACTURING I, LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Young Dental Manufacturing I, Llc
Sources (1)
- FDA UDI dd7e0455-832d-4b99-bf9f-b79b24a7b4a3 36 fields · synced May 30, 2026