Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MICROPREP CAVITY PREPERATION SYSTEM

K-Number: K932997 · 1994-04-25

Decision Date1994-04-25
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICROPREP CAVITY PREPERATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Technologies, Inc.. It received FDA 510(k) clearance on 1994-04-25 under 510(k) number K932997. 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 MICROPREP CAVITY PREPERATION SYSTEM?

MICROPREP CAVITY PREPERATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K932997.

When did MICROPREP CAVITY PREPERATION SYSTEM receive FDA 510(k) clearance?

MICROPREP CAVITY PREPERATION SYSTEM received FDA 510(k) clearance on 1994-04-25, under 510(k) number K932997.

Who is the listed applicant for MICROPREP CAVITY PREPERATION SYSTEM?

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

What is the FDA product code for MICROPREP CAVITY PREPERATION SYSTEM?

The FDA product code for MICROPREP CAVITY PREPERATION SYSTEM 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.

Other records listing Sunrise Technologies, 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.

View all 18 devices →

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.

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.

↑