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FDA 510(k)

BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS

K-Number: K112875 · 2012-01-27

ApplicantBlue Sky Bio, LLC
Decision Date2012-01-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS 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 2012-01-27 under 510(k) number K112875. 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 TAPER HEX IMPLANT SYSTEMS?

BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-01-27. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K112875.

When did BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS receive FDA 510(k) clearance?

BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS received FDA 510(k) clearance on 2012-01-27, under 510(k) number K112875.

Who is the listed applicant for BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS?

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 DENTAL TAPER HEX IMPLANT SYSTEMS?

The FDA product code for BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS is DZE.

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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.

K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXK221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GK212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsK202026Blue Sky Bio CAD-CAM AbutmentsK201919Blue Sky Bio TADK190491Blue Sky Bio Zygomatic Implant System

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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

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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