Identity
- Trade Name
- Paltop FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Guided Countersink Ø5mm FDA UDI
- Model / Reference
- 30-70328 FDA UDI
- Description
- Guided Countersink Ø5mm FDA UDI
Identifiers
- Catalog Number
- 30-70328 FDA UDI
- Primary DI / UDI-DI
- 07290108698008 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 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
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
Category: Fixture/appliance dental drill bit, reusable
Paltop is a high-quality, guided countersink drill designed for dental professionals. This device features a sturdy shaft, precise rotation, and easy-to-use design, making it an ideal tool for creating optimal bone channels in the oral cavity.
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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
- Paltop Advanced Dental Solutions, Ltd.
Sources (1)
- FDA UDI 887c62f3-d5d7-4461-9050-ad833b2c6937 35 fields · synced Oct 6, 2026