Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- CSS-2 Composite System FDA UDI
- Model / Reference
- R514 CSS-2 Composite System FDA UDI
- Description
- CSS-2 Composite System FDA UDI
Identifiers
- Catalog Number
- R514 FDA UDI
- Primary DI / UDI-DI
- 00813677022134 FDA UDI
- FDA Product Code
- EIY FDA UDI
- GMDN Term
- Dental spatula, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental spatula, reusable
PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Power Dental USA — Power Dental USA, Inc. · Class I
- Power Dental USA — Power Dental USA, Inc. · 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
- PDT, Inc.
Sources (1)
- FDA UDI 9fd3826e-d151-4445-8614-3b0cd27eb753 34 fields · synced Jun 9, 2026