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FDA 510(k)

MEGABEAM DENTAL FIBER

K-Number: K942182 · 1994-07-06

ApplicantCeram Optec, Inc.
Decision Date1994-07-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGABEAM DENTAL FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K942182. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGABEAM DENTAL FIBER?

MEGABEAM DENTAL FIBER is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K942182.

When did MEGABEAM DENTAL FIBER receive FDA 510(k) clearance?

MEGABEAM DENTAL FIBER received FDA 510(k) clearance on 1994-07-06, under 510(k) number K942182.

Who is the listed applicant for MEGABEAM DENTAL FIBER?

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

What is the FDA product code for MEGABEAM DENTAL FIBER?

The FDA product code for MEGABEAM DENTAL FIBER is GEX. This falls under the Gastroenterology category.

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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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