Identity
- Trade Name
- D-Lish Assorted Varnish 200 FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing FDA UDI
- Model / Reference
- 295484 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10302732954840 FDA UDI
- 510(k) Number
- K080814 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing 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
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
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
D-Lish Assorted Varnish 200 by Young Dental Manufacturing I, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Caramel — Preventech · Class II
- VOCO Profluorid Varnish — VOCO GmbH · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- IRIS — BENCO DENTAL SUPPLY CO. · Class II
- Pulp Canal Sealer — KERR ITALIA SRL · Class IIa
- MICROPRIME — DANVILLE MATERIALS, LLC · Class II
- VOCO Profluorid Varnish — VOCO GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Young Dental Manufacturing I, Llc
Sources (1)
- FDA UDI f91cfbeb-d6c4-484b-a2b2-8fd6c6e93206 33 fields · synced May 30, 2026