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FDA 510(k)

SL3

K-Number: K102639 · 2010-12-01

ApplicantDiscus Dental, LLC
Decision Date2010-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SL3 is the device name listed in this FDA 510(k) record. The listed applicant is Discus Dental, LLC. It received FDA 510(k) clearance on 2010-12-01 under 510(k) number K102639. 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 SL3?

SL3 is a medical device that received FDA 510(k) clearance on 2010-12-01. The listed applicant is Discus Dental, LLC. The 510(k) number is K102639.

When did SL3 receive FDA 510(k) clearance?

SL3 received FDA 510(k) clearance on 2010-12-01, under 510(k) number K102639.

Who is the listed applicant for SL3?

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

What is the FDA product code for SL3?

The FDA product code for SL3 is GEX. This falls under the Gastroenterology category.

Other records listing Discus Dental, LLC 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.

K101612ZEN CORDLESS PROPHY SYSTEMK101215NUANCEK093208SIMPLISEALK092417INSIGHT ULTRASONIC INSERTS

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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