Cleared Traditional

K102034 - BLUE SKY BIO DENTAL IMPLANT SYSTEM

K102034 is an FDA 510(k) clearance for BLUE SKY BIO DENTAL 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 274-day FDA review.

K102034 · Blue Sky Bio, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
274d
Days
Class 2
Risk

K102034 is an FDA 510(k) clearance for the BLUE SKY BIO DENTAL 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 19, 2011 after a review of 274 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 - K102034

510(k) Number K102034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2010
Decision Date April 19, 2011
Days to Decision 274 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
147d slower than avg
Panel avg: 127d · This submission: 274d
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 K102034.
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ET III SA ULTRA WIDE SYSTEM
K103537 · Hiossen, Inc. · Mar 2011
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
NOBEL ACTIVE 3.0
K102436 · Nobel Biocare AB · Dec 2010