Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- R218 - The Montana Precision Probe is used to assess periodontal clinical attachment, the probe is a measuring instrument with demarcation in millimeters (mm). The Montana Precision Probe™ provides an innovative angled offset shank to allow for easier access to periodontal pocket areas, specifically in the posterior regions. Much like paired scalers and curettes, the Montana Precision Probe™ can reach around bulbous enamel areas to more accurately record periodontal numbers. It is marked with the common UNC 12 pattern of 1-2-3-4-5-6-7-8-9-10-11-12 mm on both ends. FDA UDI
- Model / Reference
- R218 Montana Precision Probe FDA UDI
- Description
- R218 - The Montana Precision Probe is used to assess periodontal clinical attachment, the probe is a measuring instrument with demarcation in millimeters (mm). The Montana Precision Probe™ provides an innovative angled offset shank to allow for easier access to periodontal pocket areas, specifically in the posterior regions. Much like paired scalers and curettes, the Montana Precision Probe™ can reach around bulbous enamel areas to more accurately record periodontal numbers. It is marked with the common UNC 12 pattern of 1-2-3-4-5-6-7-8-9-10-11-12 mm on both ends. FDA UDI
Identifiers
- Catalog Number
- R218 FDA UDI
- Primary DI / UDI-DI
- 00813677025241 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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 74991f4f-0e80-4d3e-ba1c-7f3c2faff488 35 fields · synced Jun 9, 2026