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FDA 510(k)

OPUS 20, MODEL 1ST

K-Number: K002899 · 2000-12-12

ApplicantOpusdent , Ltd.
Decision Date2000-12-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPUS 20, MODEL 1ST is the device name listed in this FDA 510(k) record. The listed applicant is Opusdent , Ltd.. It received FDA 510(k) clearance on 2000-12-12 under 510(k) number K002899. 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 OPUS 20, MODEL 1ST?

OPUS 20, MODEL 1ST is a medical device that received FDA 510(k) clearance on 2000-12-12. The listed applicant is Opusdent , Ltd.. The 510(k) number is K002899.

When did OPUS 20, MODEL 1ST receive FDA 510(k) clearance?

OPUS 20, MODEL 1ST received FDA 510(k) clearance on 2000-12-12, under 510(k) number K002899.

Who is the listed applicant for OPUS 20, MODEL 1ST?

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

What is the FDA product code for OPUS 20, MODEL 1ST?

The FDA product code for OPUS 20, MODEL 1ST 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 Opusdent , Ltd. 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.

K021508OPUSDUO EC DENTAL LASER SYSTEMK014100OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2NDK011769OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2NDK000990OPUS 10 DENTAL DIODE LASER

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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