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FDA 510(k)

Blue Sky Bio CAD-CAM Abutments

K-Number: K202026 · 2020-12-18

Decision Date2020-12-18
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Blue Sky Bio CAD-CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K202026. 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 Blue Sky Bio CAD-CAM Abutments?

Blue Sky Bio CAD-CAM Abutments is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K202026.

When did Blue Sky Bio CAD-CAM Abutments receive FDA 510(k) clearance?

Blue Sky Bio CAD-CAM Abutments received FDA 510(k) clearance on 2020-12-18, under 510(k) number K202026.

Who is the listed applicant for Blue Sky Bio CAD-CAM Abutments?

The FDA 510(k) record lists Blue Sky Bio, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Sky Bio CAD-CAM Abutments?

The FDA product code for Blue Sky Bio CAD-CAM Abutments is NHA.

Other records listing Blue Sky Bio, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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