Identity
- Trade Name
- Bite Dx Occlusal Pain Diagnostic Instruments FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 7136615 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 71-36615 FDA UDI
- Primary DI / UDI-DI
- 00723896008836 FDA UDI
- FDA Product Code
- DZN 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
Bite Dx Occlusal Pain Diagnostic Instruments by Practicon, 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
- Practicon, Inc.
Sources (1)
- FDA UDI c93de254-9254-41b1-8241-b03e4be74c40 34 fields · synced May 30, 2026