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FDA 510(k)

DIBS (Digital Indirect Bonding System)

K-Number: K192701 · 2020-04-21

ApplicantOrthoselect, LLC
Decision Date2020-04-21
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIBS (Digital Indirect Bonding System) is a medical device manufactured by Orthoselect, LLC. It received FDA 510(k) clearance on 2020-04-21 under approval number K192701. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIBS (Digital Indirect Bonding System)?

DIBS (Digital Indirect Bonding System) is a medical device that received FDA 510(k) clearance on 2020-04-21. It is manufactured by Orthoselect, LLC. The 510(k) number is K192701.

When was DIBS (Digital Indirect Bonding System) approved by the FDA?

DIBS (Digital Indirect Bonding System) received FDA 510(k) clearance on 2020-04-21, under approval number K192701.

What company makes DIBS (Digital Indirect Bonding System)?

DIBS (Digital Indirect Bonding System) is manufactured by Orthoselect, LLC.

What is the FDA product code for DIBS (Digital Indirect Bonding System)?

The FDA product code for DIBS (Digital Indirect Bonding System) is PNN.

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

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Official Source

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