Identity
- Trade Name
- ProphyCare FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Model / Reference
- Red 120 FDA UDI
Identifiers
- Catalog Number
- 731112 FDA UDI
- Primary DI / UDI-DI
- 17310237311122 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6030 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dentifrice
ProphyCare by Directa AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
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- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Directa AB
Sources (1)
- FDA UDI adbb75a7-69f9-403d-b1fc-cb35296012b8 33 fields · synced May 31, 2026