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)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 128d · 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 Consultant

PaxMed International, LLC
Kevin A Thomas

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1375
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K153064.
IBS Implant System
K153350 · Innobiosurg Co., Ltd. · May 2016
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K153111 · Adin Dental Implants Systems , Ltd. · May 2016
BTI Dental Implant System UnicCa
K151391 · B.T.I. Biotechnology Institute, Sl. · May 2016
maxFit II Dental Implant System
K151588 · Taiwan Implant Technology Company, Ltd. · Apr 2016
TREFOIL System
K152836 · Nobel Biocare AB · Apr 2016
Noris Medical MBI Dental Implant System
K153043 · Noris Medical , Ltd. · Apr 2016