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FDA 510(k)

PERMALUX VISIBLE CURE COMPOSITE RESTOR

K-Number: K831351 · 1983-11-14

ApplicantLares Manufacturing Co., Inc.
Decision Date1983-11-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMALUX VISIBLE CURE COMPOSITE RESTOR is the device name listed in this FDA 510(k) record. The listed applicant is Lares Manufacturing Co., Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K831351. 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 PERMALUX VISIBLE CURE COMPOSITE RESTOR?

PERMALUX VISIBLE CURE COMPOSITE RESTOR is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Lares Manufacturing Co., Inc.. The 510(k) number is K831351.

When did PERMALUX VISIBLE CURE COMPOSITE RESTOR receive FDA 510(k) clearance?

PERMALUX VISIBLE CURE COMPOSITE RESTOR received FDA 510(k) clearance on 1983-11-14, under 510(k) number K831351.

Who is the listed applicant for PERMALUX VISIBLE CURE COMPOSITE RESTOR?

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

What is the FDA product code for PERMALUX VISIBLE CURE COMPOSITE RESTOR?

The FDA product code for PERMALUX VISIBLE CURE COMPOSITE RESTOR is EBF.

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Other records listing Lares Manufacturing Co., 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.

K801535LARES HANDPIECE OILK801592FIBER OPTIC HOSEK801591FIBER OPTIC ILLUMINATORK801534LARES AIR PRESSURE GAUGEK780038DENTAL HANDPIECE

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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