FDA 510(k)

UF(II) Anatomic abutment

K-Number: K190048 · 2019-09-30

Decision Date2019-09-30

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UF(II) Anatomic abutment is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2019-09-30 under approval number K190048. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UF(II) Anatomic abutment?

UF(II) Anatomic abutment is a medical device that received FDA 510(k) clearance on 2019-09-30. It is manufactured by Dio Corporation. The 510(k) number is K190048.

When was UF(II) Anatomic abutment approved by the FDA?

UF(II) Anatomic abutment received FDA 510(k) clearance on 2019-09-30, under approval number K190048.

What company makes UF(II) Anatomic abutment?

UF(II) Anatomic abutment is manufactured by Dio Corporation.

What is the FDA product code for UF(II) Anatomic abutment?

The FDA product code for UF(II) Anatomic abutment is NHA.

Other Devices by Dio Corporation

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.