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FDA 510(k)

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

K-Number: K241003 · 2025-01-08

ApplicantHiossen, Inc.
Decision Date2025-01-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2025-01-08 under approval number K241003. 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 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by Hiossen, Inc.. The 510(k) number is K241003.

When was HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) approved by the FDA?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) received FDA 510(k) clearance on 2025-01-08, under approval number K241003.

What company makes HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is manufactured by Hiossen, Inc..

What is the FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

The FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is NHA.

Other Devices by Hiossen, Inc.

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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.

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