Cleared Special

K021833 - MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021833 · Blue Sky Bio · Dental device
Jun 2002
Decision
6d
Days
Class 2
Risk

K021833 is an FDA 510(k) clearance for the MODIFICATION TO BLUE SKY 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 June 10, 2002 after a review of 6 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K021833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2002
Decision Date June 10, 2002
Days to Decision 6 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
152d faster than avg
Panel avg: 158d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 69
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K021833.
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