FDA UDI
In Commercial Distribution
🇺🇸 United States
Bite Dx Occlusal Pain Diagnostic Instruments
DI: 00723896008836
·
Model: 7136615
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Bite Dx Occlusal Pain Diagnostic Instruments
- Primary DI
- 00723896008836
- Version / Model
- 7136615
- Catalog Number
- 71-36615
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-07-19
- Public Version
- 2
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- c93de254-9254-41b1-8241-b03e4be74c40
Device Description
While competitive products work well to identify fractures and to isolate pain associated with a single cusp, their small size and hard plastic construction slip around and are inadequate for diagnosing chewing pain unrelated to cracked teeth. The Bite Dx Occlusal Pain Diagnostic Instrument allows the patient to bite down onto soft, non-slip elastomer pads with all cusps of a single tooth at one time to detect chewing pain on all types of teeth. Helps diagnose PDL inflammation and the spread of pulpitis to the apical ligament, in addition to cracks. Tough polypropylene handle also features a traditional pyramid-shaped end for cusp fracture detection. Fully autoclavable
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | 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 | 00723896008836 | GS1 | ||||
| Unit of Use | 00723896008829 | GS1 |