Cleared Traditional

K073713 - BLUE SKY BIO DENTAL IMPLANT SYSTEM

K073713 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 88-day FDA review.

K073713 · Blue Sky Bio, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
88d
Days
Class 2
Risk

K073713 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 March 28, 2008 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Blue Sky Bio, LLC devices

FDA 510(k) Submission Details - K073713

510(k) Number K073713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date March 28, 2008
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 766
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K073713.
US/GS ULTRA WIDE SYSTEM
K073465 · Osstem Implant Co., Ltd. · Apr 2008
DENTIS DENTAL IMPLANT SYSTEM
K073486 · Dentis Co., Ltd. · Apr 2008
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · Dentsply International, Inc. · Mar 2008
JNE IMPLANT SYSTEM
K072425 · GC America, Inc. · Mar 2008
US/SS/GS SYSTEM
K073247 · Osstem Implant Co., Ltd. · Mar 2008
HU II / HS II FIXTURE SYSTEM
K080387 · Osstem Implant Co., Ltd. · Mar 2008