Identity
- Trade Name
- Listerine FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, home-use FDA UDI
- Device Name
- LISTERINE CLINICAL SOLUTIONS SENSITIVE TEETH 95ML FDA UDI
- Model / Reference
- 00312547202299 FDA UDI
- Description
- LISTERINE CLINICAL SOLUTIONS SENSITIVE TEETH 95ML FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00312547202299 FDA UDI
- 510(k) Number
- K143155 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, home-use 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
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
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, home-use
Listerine by Kenvue Brands LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing, home-use.
- GC Fuji TRIAGE® — Gc America Inc. · Class II
- Nanodent — Phoenix Dental, Inc. · Class II
- Listerine — Kenvue Brands LLC · Class II
Cleared under the same submission
K143155 also covers:
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
- Kenvue Brands LLC
Sources (1)
- FDA UDI e2be0d25-5c57-4863-8ddf-8bf3f88199b4 35 fields · synced Jun 8, 2026