Identity
- Trade Name
- I-pak FDA UDI
- Generic Name
- Periodontal probe, reusable FDA UDI
- Device Name
- Sterile Dental I-pak (Intraoral Exam pack) with mirror, probe & explorer. Disposable. FDA UDI
- Model / Reference
- D002-009-P FDA UDI
- Description
- Sterile Dental I-pak (Intraoral Exam pack) with mirror, probe & explorer. Disposable. FDA UDI
Identifiers
- Catalog Number
- D002-009-P FDA UDI
- Primary DI / UDI-DI
- 00814639020694 FDA UDI
- FDA Product Code
- EAX FDA UDIEIX FDA UDIEKB FDA UDI
- GMDN Term
- Periodontal 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental surgical probe, reusableDental mirror, reusablePeriodontal probe, reusable
I-pak by Applied Dental, 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
- Applied Dental, Inc.
Sources (1)
- FDA UDI d99b59ee-fed6-47e6-91d1-1f116156bc33 36 fields · synced Jun 8, 2026