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FDA 510(k)

BLUE SKY BIO DENTAL IMPLANT SYSTEM

K-Number: K010882 · 2001-09-28

ApplicantBlue Sky Bio
Decision Date2001-09-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUE SKY BIO 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 2001-09-28 under 510(k) number K010882. 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 BLUE SKY BIO DENTAL IMPLANT SYSTEM?

BLUE SKY BIO DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Blue Sky Bio. The 510(k) number is K010882.

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

BLUE SKY BIO DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2001-09-28, under 510(k) number K010882.

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

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

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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 SystemK021833MODIFICATION TO BLUE SKY 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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