Identity
- Trade Name
- Young PerioDT FDA UDI
- Generic Name
- Dental mouthwash FDA UDI
- Device Name
- Young PerioDT Gel Biofilm Debridement Sulfonated Phenolics, 0.5mL, 10pk FDA UDI
- Model / Reference
- 100278 FDA UDI
- Description
- Young PerioDT Gel Biofilm Debridement Sulfonated Phenolics, 0.5mL, 10pk FDA UDI
Identifiers
- Catalog Number
- 100278 FDA UDI
- Primary DI / UDI-DI
- 00840326420348 FDA UDI
- 510(k) Number
- K201785 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental mouthwash
Young PerioDT by Young Innovations, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental mouthwash.
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- Effervescent Mouth Wash Tablets (1000 pieces) — Produits dentaires S.A. · Class I
- OroGenix Oral Hygiene Rinse — Sonoma Pharmaceuticals, Inc. · U
- Bosma Enterprises — Bosma Enterprises · Class I
- OroGenix Oral Hygiene Rinse — Sonoma Pharmaceuticals, Inc. · U
Cleared under the same submission
K201785 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 U | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI 6621fd84-3930-4b7b-a536-55f6f6b18caa 37 fields · synced May 31, 2026