Identity
- Trade Name
- Lamineer Tips FDA UDI
- Generic Name
- Dental abrasive disk, reusable FDA UDI
- Device Name
- Flex Lamineer Tip Assortment Pack for Profin Reciprocating Contra-Angles Single Sided 50, 75 and 100 Micron Diamond Coating, 1 of Each FDA UDI
- Model / Reference
- LTA-F FDA UDI
- Description
- Flex Lamineer Tip Assortment Pack for Profin Reciprocating Contra-Angles Single Sided 50, 75 and 100 Micron Diamond Coating, 1 of Each FDA UDI
Identifiers
- Catalog Number
- LTA-F FDA UDI
- Primary DI / UDI-DI
- 07350081495305 FDA UDI
- FDA Product Code
- EHL FDA UDI
- GMDN Term
- Dental abrasive disk, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive disk, reusable
Lamineer Tips by Dentatus AB — 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
- Dentatus AB
Sources (1)
- FDA UDI 2714b2d3-2ac6-4ace-8928-831d67eaf51b 34 fields · synced Jun 8, 2026