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FDA 510(k)

LUMA LIGHT 2000 CURE LIGHT

K-Number: K992102 · 1999-08-31

ApplicantLumalite, Inc.
Decision Date1999-08-31
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUMA LIGHT 2000 CURE LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Lumalite, Inc.. It received FDA 510(k) clearance on 1999-08-31 under 510(k) number K992102. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMA LIGHT 2000 CURE LIGHT?

LUMA LIGHT 2000 CURE LIGHT is a medical device that received FDA 510(k) clearance on 1999-08-31. The listed applicant is Lumalite, Inc.. The 510(k) number is K992102.

When did LUMA LIGHT 2000 CURE LIGHT receive FDA 510(k) clearance?

LUMA LIGHT 2000 CURE LIGHT received FDA 510(k) clearance on 1999-08-31, under 510(k) number K992102.

Who is the listed applicant for LUMA LIGHT 2000 CURE LIGHT?

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

What is the FDA product code for LUMA LIGHT 2000 CURE LIGHT?

The FDA product code for LUMA LIGHT 2000 CURE LIGHT is EBF.

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 Lumalite, Inc. 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.

K021083VERACAMK002566LUMALITE CURE LIGHT, MODEL 2100

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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