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FDA 510(k)

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6

K-Number: K980216 · 1998-06-16

ApplicantKreativ, Inc.
Decision Date1998-06-16
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 is the device name listed in this FDA 510(k) record. The listed applicant is Kreativ, Inc.. It received FDA 510(k) clearance on 1998-06-16 under 510(k) number K980216. 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 KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6?

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 is a medical device that received FDA 510(k) clearance on 1998-06-16. The listed applicant is Kreativ, Inc.. The 510(k) number is K980216.

When did KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 receive FDA 510(k) clearance?

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 received FDA 510(k) clearance on 1998-06-16, under 510(k) number K980216.

Who is the listed applicant for KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6?

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

What is the FDA product code for KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6?

The FDA product code for KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 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 Kreativ, Inc. 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.

K990060MACH 7K983227POWER BLOCKK962376KREATIV KURING LIGHT SYSTEMK940776KREATIV MODEL KV-1

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 CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, Inc.

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.

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