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FDA 510(k)

AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP

K-Number: K923539 · 1992-10-28

ApplicantAmerican Dental Laser, Inc.
Decision Date1992-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Laser, Inc.. It received FDA 510(k) clearance on 1992-10-28 under 510(k) number K923539. 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 AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP?

AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP is a medical device that received FDA 510(k) clearance on 1992-10-28. The listed applicant is American Dental Laser, Inc.. The 510(k) number is K923539.

When did AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP receive FDA 510(k) clearance?

AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP received FDA 510(k) clearance on 1992-10-28, under 510(k) number K923539.

Who is the listed applicant for AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP?

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

What is the FDA product code for AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP?

The FDA product code for AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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