Cleared Traditional

K010882 - BLUE SKY BIO DENTAL IMPLANT SYSTEM

K010882 is an FDA 510(k) clearance for BLUE SKY BIO DENTAL IMPLANT SYSTEM, manufactured by Blue Sky Bio. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K010882 · Blue Sky Bio · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
189d
Days
Class 2
Risk

K010882 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 (Chicago, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 189 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 devices

FDA 510(k) Submission Details - K010882

510(k) Number K010882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date September 28, 2001
Days to Decision 189 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
62d slower than avg
Panel avg: 127d · This submission: 189d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010882.
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · BioHorizons Implant Systems, Inc. · Jan 2002
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · Institut Straumann AG · Dec 2001
OSSEOTITE DENTAL IMPLANTS
K013570 · Implant Innovations, Inc. · Dec 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · Implant Innovations, Inc. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · Lifecore Biomedical, Inc. · May 2001