FDA 510(k)

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200

K-Number: K983168 · 1998-11-18

Decision Date1998-11-18

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 is the device name listed in this FDA 510(k) record. The listed applicant is Ora Innovations, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983168. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200?

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Ora Innovations, Inc.. The 510(k) number is K983168.

When did AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 receive FDA 510(k) clearance?

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983168.

Who is the listed applicant for AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200?

The FDA 510(k) record lists Ora Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200?

The FDA product code for AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 is EFB.

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Related Devices (Code: EFB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.