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FDA 510(k)

MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM

K-Number: K021833 · 2002-06-10

ApplicantBlue Sky Bio
Decision Date2002-06-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio. It received FDA 510(k) clearance on 2002-06-10 under 510(k) number K021833. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM?

MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-10. The listed applicant is Blue Sky Bio. The 510(k) number is K021833.

When did MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2002-06-10, under 510(k) number K021833.

Who is the listed applicant for MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM?

The FDA product code for MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM is DZE.

Related Clinical Trials

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Other records listing Blue Sky Bio 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.

K182338Blue Sky Bio Computerized Orthodontic Bracket SystemK163251Life Essence Universal Porcelain SystemK010882BLUE SKY BIO DENTAL IMPLANT SYSTEMK000633SYNTHETIC GLASS BONE GRAFT MATERIAL

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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.

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