Identity
- Trade Name
- Paltop FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Advanced + Dental Implant Ø3mm L11.5mm FDA UDI
- Model / Reference
- 20-70035P FDA UDI
- Description
- Advanced + Dental Implant Ø3mm L11.5mm FDA UDI
Identifiers
- Catalog Number
- 20-70035P FDA UDI
- Primary DI / UDI-DI
- 07290114690683 FDA UDI
- 510(k) Number
- K210117 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Screw endosteal dental implant, two-piece
A detailed overview of the Paltop advanced dental implant, including its features, compliance, and usage instructions. Learn how this device works, what makes it unique, and what to expect when using it.
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K210117 also covers:
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
- Paltop — Paltop Advanced Dental Solutions, Ltd.
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
- Paltop Advanced Dental Solutions, Ltd.
Sources (1)
- FDA UDI 7ebe2103-f085-45b6-ba50-c4bb57c9a42a 36 fields · synced Jun 19, 2026