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FDA 510(k)

ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1

K-Number: K964145 · 1996-12-31

ApplicantCrystal Mark, Inc.
Decision Date1996-12-31
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 is the device name listed in this FDA 510(k) record. The listed applicant is Crystal Mark, Inc.. It received FDA 510(k) clearance on 1996-12-31 under 510(k) number K964145. 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 ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1?

ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 is a medical device that received FDA 510(k) clearance on 1996-12-31. The listed applicant is Crystal Mark, Inc.. The 510(k) number is K964145.

When did ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 receive FDA 510(k) clearance?

ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 received FDA 510(k) clearance on 1996-12-31, under 510(k) number K964145.

Who is the listed applicant for ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1?

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

What is the FDA product code for ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1?

The FDA product code for ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 is KOJ.

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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.

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