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UF(II) Narrow Implant System

FDA UDI

Class II (US FDA UDI)

by DIO Corporation

Identity

Trade Name
UF(II) Narrow Implant System FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Model / Reference
UNSHA 4547 FDA UDI

Identifiers

Catalog Number
UNSHA 4547 FDA UDI
Primary DI / UDI-DI
08806195974995 FDA UDI
510(k) Number
K161987 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

UF(II) Narrow Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K161987 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DIO Corporation

Sources (1)

  • FDA UDI 3084f35a-a860-4dad-bf62-54360bfefd46 35 fields · synced May 31, 2026