Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable FDA UDI
- Device Name
- SENSITIP KIT FDA UDI
- Model / Reference
- 263485 FDA UDI
- Description
- SENSITIP KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022634850 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
StarDental Instrument Solutions by Dentalez, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dentalez, Inc.
Sources (1)
- FDA UDI fa1929fa-21c8-4ea0-9f6f-28238191d173 35 fields · synced May 30, 2026