Cleared Traditional

K051507 - MODIFICATION TO BLUE SKY BIO DENTAL IMP...

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · 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 766
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K051507.
MAXIMUS 3.0 AND OS IMPLANTS
K052419 · BioHorizons Implant Systems, Inc. · Sep 2005
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
SPI DENTAL IMPLANT
K051502 · Thommen Medical AG · Jun 2005
NOBELSPEEDY IMPLANTS
K050406 · Nobel Biocare AB · Jun 2005
PREVAIL DENTAL IMPLANTS
K051189 · Implant Innovations, Inc. · Jun 2005