Identity
- Trade Name
- Profin FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Profin E-Type Reciprocating Contra-Angle General Starter Kit with Assorted Lamineer Tips and Accessories - Lamineer Tips Single Sided Diamond Coated, 1 of Each: LTA-30, LTA-39, LTA-150, LTA-S50 and LTA-S100 - Plastic Polishing Tips, 30 Pcs. - Tip Plunger FDA UDI
- Model / Reference
- PDX/SK FDA UDI
- Description
- Profin E-Type Reciprocating Contra-Angle General Starter Kit with Assorted Lamineer Tips and Accessories - Lamineer Tips Single Sided Diamond Coated, 1 of Each: LTA-30, LTA-39, LTA-150, LTA-S50 and LTA-S100 - Plastic Polishing Tips, 30 Pcs. - Tip Plunger FDA UDI
Identifiers
- Catalog Number
- PDX/SK FDA UDI
- Primary DI / UDI-DI
- 07350081491826 FDA UDI
- FDA Product Code
- EGS FDA UDIEHL FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI872.6010 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive disk, reusableDental surgical power tool motorized handpiece/set, electric
Profin by Dentatus AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MAXSO — Beyes Dental Canada Inc · Class I
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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
- Dentatus AB
Sources (1)
- FDA UDI 5e252289-b115-4e55-a174-4f1bc2804ad3 34 fields · synced May 30, 2026