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FDA 510(k)

RONDOFLEX PLUS 360

K-Number: K042872 · 2004-11-23

ApplicantKavo America Corporation
Decision Date2004-11-23
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RONDOFLEX PLUS 360 is the device name listed in this FDA 510(k) record. The listed applicant is Kavo America Corporation. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K042872. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RONDOFLEX PLUS 360?

RONDOFLEX PLUS 360 is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Kavo America Corporation. The 510(k) number is K042872.

When did RONDOFLEX PLUS 360 receive FDA 510(k) clearance?

RONDOFLEX PLUS 360 received FDA 510(k) clearance on 2004-11-23, under 510(k) number K042872.

Who is the listed applicant for RONDOFLEX PLUS 360?

The FDA 510(k) record lists Kavo America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RONDOFLEX PLUS 360?

The FDA product code for RONDOFLEX PLUS 360 is KOJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Kavo America Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042394DIAGNODENT PERIO TIP (ACCESSORY)K050744KAVO ERGOCOM/ERGOCAMK033221KAVO EVEREST ZH-BLANK

Related Devices (Code: KOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, Inc.K030292GROMAN PREPMASTERGroman, Inc.

Official Source

View on FDA Database →

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

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