Identity
- Trade Name
- OroGenix Antiplaque Tooth Gel FDA UDI
- Generic Name
- Dental mouthwash FDA UDI
- Model / Reference
- P-E1215T00 FDA UDI
Identifiers
- Catalog Number
- P-E1215T00 FDA UDI
- Primary DI / UDI-DI
- 00850015491146 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- GMDN Term
- Dental mouthwash FDA UDI
Classification
- Device Class
- U 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
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
Dimensions & Sizes
- Size
- Weight — 86 Gram FDA UDI
Category: Dental mouthwash
OroGenix Antiplaque Tooth Gel by Sonoma Pharmaceuticals, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental mouthwash.
- Effervescent Mouth Wash Tablets (500 pieces) — Produits dentaires S.A. · Class I
- Young PerioDT — Young Innovations, Inc. · U
- Young PerioDT — Young Innovations, Inc. · U
- Effervescent Mouth Wash Tablets — Produits dentaires S.A. · Class I
- Young PerioDT — Young Innovations, Inc. · U
- Bosma Enterprises — Bosma Enterprises · Class I
- Effervescent Mouth Wash Tablets (1000 pieces) — Produits dentaires S.A. · Class I
- Young PerioDT — Young Innovations, Inc. · U
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 U | Pending data |
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Manufacturer
- Manufacturer
- Sonoma Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 9550836e-1de8-4a49-a5ac-6998b146d21f 35 fields · synced May 30, 2026