Cleared Traditional

K153064 - Blue Sky Bio Zygomatic Implant System

K153064 is an FDA 510(k) clearance for Blue Sky Bio Zygomatic Implant System, manufactured by Blue Sky Bio, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K153064 · Blue Sky Bio, LLC · Dental device
Download Printable Device Report (PDF)
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Apr 2016
Decision
190d
Days
Class 2
Risk

K153064 is an FDA 510(k) clearance for the Blue Sky Bio Zygomatic Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Blue Sky Bio, LLC (Grayslake, US). The FDA issued a Cleared decision on April 29, 2016 after a review of 190 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Blue Sky Bio, LLC devices

FDA 510(k) Submission Details - K153064

510(k) Number K153064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2015
Decision Date April 29, 2016
Days to Decision 190 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 764
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K153064.
s-Clean Tapered II RBM Implant System
K160213 · Dentis Co., Ltd. · Jun 2016
NobelSpeedy Groovy
K160119 · Nobel Biocare AB · Jun 2016
INCLUSIVE TAPERED IMPLANT SYSTEM
K153099 · Prismatik Dentalcraft, Inc. · May 2016
TREFOIL System
K152836 · Nobel Biocare AB · Apr 2016
OneQ-SL s-Clean Implant System
K153639 · Dentis Co., Ltd. · Apr 2016
Straumann Bone Level Tapered Implants
K153758 · Institut Straumann AG · Mar 2016