Cleared Traditional

K051507 - MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM

K051507 is an FDA 510(k) clearance for MODIFICATION TO BLUE SKY BIO DENTAL IMP..., 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 87-day FDA review.

K051507 · Blue Sky Bio, LLC · Dental device
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Sep 2005
Decision
87d
Days
Class 2
Risk

K051507 is an FDA 510(k) clearance for the MODIFICATION TO 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 September 2, 2005 after a review of 87 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 - K051507

510(k) Number K051507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2005
Decision Date September 02, 2005
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
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 1375
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K051507.
3I OSSEOTITE DENTAL IMPLANTS
K051461 · Implant Innovations, Inc. · Sep 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
K051614 · Lifecore Biomedical, Inc. · Sep 2005
INTERMEZZO IMPLANT SYSTEMS
K051018 · Megagen Co., Ltd. · Sep 2005
AVANA DENTAL IMPLANT SYSTEM
K051576 · Osstem Co., Ltd. · Sep 2005
ALLFIM IMPLANT SYSTEMS
K050635 · Cowellmedi Co., Ltd. · Jul 2005
SPI DENTAL IMPLANT
K051502 · Thommen Medical AG · Jun 2005