Cleared Traditional

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments (K212785) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212785 · Blue Sky Bio, LLC · Dental device
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Jun 2022
Decision
302d
Days
Class 2
Risk

K212785 is an FDA 510(k) clearance for the Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Blue Sky Bio, LLC (Libertyville, US). The FDA issued a Cleared decision on June 30, 2022 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, LLC devices

Submission Details

510(k) Number K212785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2021
Decision Date June 30, 2022
Days to Decision 302 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
175d slower than avg
Panel avg: 127d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K212785.
Kontact Dental Implant System
K213997 · Biotech Dental, Sas · Jul 2022
SNUCONE Bone Level Implant System
K210354 · Snucone Co., Ltd. · Jul 2022
Adin Short Implants
K212775 · Adin Dental Implants Systems , Ltd. · Jul 2022
Noris Medical Dental Implants System - Cortical
K210852 · Noris Medical , Ltd. · Jun 2022
Paltop Conical Implant System
K220200 · Paltop Advanced Dental Solutions, Ltd. · May 2022
ZENEX Implant System
K211090 · Izenimplant Co., Ltd. · Apr 2022