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Paltop

FDA UDI

Class II (US FDA UDI)

by Paltop Advanced Dental Solutions, Ltd.

Identity

Trade Name
Paltop FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Titanium Angulated Abutment Internal Hex Slim Knife Edge SP 15° H 7 mm FDA UDI
Model / Reference
40-70116 FDA UDI
Description
Titanium Angulated Abutment Internal Hex Slim Knife Edge SP 15° H 7 mm FDA UDI

Identifiers

Catalog Number
40-70116 FDA UDI
Primary DI / UDI-DI
07290108699005 FDA UDI
510(k) Number
K131451 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Conditional FDA UDI

Paltop by Paltop Advanced Dental Solutions, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131451 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paltop Advanced Dental Solutions, Ltd.

Sources (1)

  • FDA UDI eddf7e23-2369-4b23-94ac-c721ec015701 37 fields · synced May 30, 2026