FDA UDI
In Commercial Distribution
🇺🇸 United States
PDT, Inc.
DI: 00813677025241
·
Model: R218 Montana Precision Probe
·
PDT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PDT, Inc.
- Primary DI
- 00813677025241
- Version / Model
- R218 Montana Precision Probe
- Catalog Number
- R218
- Company Name
- PDT, INC.
- Labeler DUNS
- 125850144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-07
- Public Version
- 2
- Public Version Date
- 2025-07-25
- Public Version Status
- Update
- Public Device Record Key
- 74991f4f-0e80-4d3e-ba1c-7f3c2faff488
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIX | Probe, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35812 | Dental surgical probe, reusable | A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813677025241 | GS1 |
Customer Contacts
- Phone
- 800-240-9895
- [email protected]