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FDA 510(k)

DENTEC LD 15 DIODE LASER

K-Number: K990680 · 1999-07-30

ApplicantDentek Lasersystems Produktions Ges.M.B.H.
Decision Date1999-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENTEC LD 15 DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Dentek Lasersystems Produktions Ges.M.B.H.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K990680. 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 DENTEC LD 15 DIODE LASER?

DENTEC LD 15 DIODE LASER is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Dentek Lasersystems Produktions Ges.M.B.H.. The 510(k) number is K990680.

When did DENTEC LD 15 DIODE LASER receive FDA 510(k) clearance?

DENTEC LD 15 DIODE LASER received FDA 510(k) clearance on 1999-07-30, under 510(k) number K990680.

Who is the listed applicant for DENTEC LD 15 DIODE LASER?

The FDA 510(k) record lists Dentek Lasersystems Produktions Ges.M.B.H. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTEC LD 15 DIODE LASER?

The FDA product code for DENTEC LD 15 DIODE LASER is GEX. This falls under the Gastroenterology category.

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 Dentek Lasersystems Produktions Ges.M.B.H. 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.

K974057DENTEK LD 15 LASERSYSTEM

Related Devices (Code: GEX)

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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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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