Identity
- Trade Name
- Paltop FDA UDI
- Generic Name
- Dental precision attachment fitting/adjustment tool FDA UDI
- Device Name
- Core Tool for Paltop Equator FDA UDI
- Model / Reference
- 60-70161 FDA UDI
- Description
- Core Tool for Paltop Equator FDA UDI
Identifiers
- Catalog Number
- 60-70161 FDA UDI
- Primary DI / UDI-DI
- 07290108699524 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental precision attachment fitting/adjustment tool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
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
Paltop by Paltop Advanced Dental Solutions, Ltd. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Paltop Advanced Dental Solutions, Ltd.
Sources (1)
- FDA UDI af0850b5-d933-4946-ba6c-cbd542ae286a 36 fields · synced Jun 1, 2026