Identity
- Trade Name
- 3DDX Straight Drill Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. FDA UDI
- Model / Reference
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable / Straight FDA UDI
- Description
- A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850073333563 FDA UDI
- FDA Product Code
- NYE FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
3DDX Straight Drill Kit by 3d Diagnostix, 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
- 3d Diagnostix, Inc.
Sources (1)
- FDA UDI 07bbe787-5a99-477c-b239-e6692bdec33b 33 fields · synced May 30, 2026