Blue Sky Bio CAD-CAM Abutments

FDA 510(k) K202026 · Blue Sky Bio, LLC

Substantially Equivalent

510(k) numberK202026

Submission

Device name
Blue Sky Bio CAD-CAM Abutments
Applicant
Blue Sky Bio, LLC
Libertyville, IL, US
Received
July 22, 2020
Decision date
December 18, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other 510(k)s with product code NHA

510(k)DeviceApplicantDecision
K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional Nobel Biocare AB08/06/2026SE
K261147Neodent Implant System - NeoConvert FitNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…07/01/2026SE
K261122Mist IcNHA · Traditional Imagine Milling Technologies, LLC06/27/2026SE
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional BioHorizons Implant Systems, Inc.06/26/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…06/15/2026SE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated Smart Denture Conversions, LLC06/11/2026SE
K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
K253774Elos Accurate® Denture Fixation SystemNHA · Traditional Elos Medtech Pinol A/S05/20/2026SE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional Hiossen, Inc.05/14/2026SE

More from Hiossen, Inc.

510(k)DeviceDecision
K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXNXC · Traditional 04/03/2024SE
K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GNXC · Abbreviated 02/24/2023SE
K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…DZE · Traditional 06/30/2022SE
K201919Blue Sky Bio TADOAT · Traditional 12/17/2020SE
K190491Blue Sky Bio Zygomatic Implant SystemNHA · Traditional 08/12/2019SE
K182338Blue Sky Bio Computerized Orthodontic Bracket SystemDYW · Traditional 11/09/2018SE
K180107Blue Sky Bio AlignerNXC · Traditional 02/09/2018SE
K163251Life Essence Universal Porcelain SystemEIH · Traditional 08/04/2017SE
K153064Blue Sky Bio Zygomatic Implant SystemDZE · Traditional 04/29/2016SE
K112875Blue Sky Bio Dental Taper Hex Implant SystemsDZE · Traditional 01/27/2012SE

Questions and answers

When was Blue Sky Bio CAD-CAM Abutments cleared by the FDA?

Blue Sky Bio CAD-CAM Abutments (K202026) received a 510(k) decision of Substantially Equivalent on December 18, 2020, 149 days after the submission was received.

What is the product code of K202026?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.