Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- R217 - The 12 OAD Hawkeye probe provides an innovative angled offset to allow for easier access to periodontal pocket areas to assess clinical attachment, specifically in the posterior regions. Much like the 11/12 explorer, paired scalers, and curettes, the 12 OAD Hawkeye can reach around bulbous enamel areas to more accurately record periodontal numbers. It is marked with the common 3-6-9-12 mm pattern on both ends and is made with a superior grade of thin surgical metal for ease of access and durability in use. This probe was created in collaboration with Dr. Emily Boge, dental administrative chair at Hawkeye Community College in Waterloo, Iowa. FDA UDI
- Model / Reference
- R217 Probe 12 OAD Hawkeye FDA UDI
- Description
- R217 - The 12 OAD Hawkeye probe provides an innovative angled offset to allow for easier access to periodontal pocket areas to assess clinical attachment, specifically in the posterior regions. Much like the 11/12 explorer, paired scalers, and curettes, the 12 OAD Hawkeye can reach around bulbous enamel areas to more accurately record periodontal numbers. It is marked with the common 3-6-9-12 mm pattern on both ends and is made with a superior grade of thin surgical metal for ease of access and durability in use. This probe was created in collaboration with Dr. Emily Boge, dental administrative chair at Hawkeye Community College in Waterloo, Iowa. FDA UDI
Identifiers
- Catalog Number
- R217 FDA UDI
- Primary DI / UDI-DI
- 00813677024374 FDA UDI
- FDA Product Code
- EIX 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
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 d150e917-0292-4aeb-915a-79575b2eeae5 35 fields · synced Jun 9, 2026