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FDA 510(k)

GAMMA LIGHT CURING DENTAL RESTORATIVE

K-Number: K823185 · 1982-11-22

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1982-11-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GAMMA LIGHT CURING DENTAL RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823185. 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 GAMMA LIGHT CURING DENTAL RESTORATIVE?

GAMMA LIGHT CURING DENTAL RESTORATIVE is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K823185.

When did GAMMA LIGHT CURING DENTAL RESTORATIVE receive FDA 510(k) clearance?

GAMMA LIGHT CURING DENTAL RESTORATIVE received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823185.

Who is the listed applicant for GAMMA LIGHT CURING DENTAL RESTORATIVE?

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

What is the FDA product code for GAMMA LIGHT CURING DENTAL RESTORATIVE?

The FDA product code for GAMMA LIGHT CURING DENTAL RESTORATIVE is EBF.

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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