Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- R169 - The PDT 11-12 Extended Reach Explorer has a tighter radius on the bends, plus an extended terminal shank, that allow for more adaptive, interproximal access for better calculus detection in deeper pockets. ODU stands for Old Dominion University. FDA UDI
- Model / Reference
- R169 Explorer ODU 11-12 ER FDA UDI
- Description
- R169 - The PDT 11-12 Extended Reach Explorer has a tighter radius on the bends, plus an extended terminal shank, that allow for more adaptive, interproximal access for better calculus detection in deeper pockets. ODU stands for Old Dominion University. FDA UDI
Identifiers
- Catalog Number
- R169 FDA UDI
- Primary DI / UDI-DI
- 00813677021144 FDA UDI
- FDA Product Code
- EKB FDA UDI
- GMDN Term
- Dental surgical probe, 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
Category: Dental surgical probe, reusable
PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 5902c46a-503d-45b0-ae07-412ce4e582b2 35 fields · synced Jun 9, 2026