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FDA 510(k)

DISTALITE POSTERIA DENTAL RESTORATIVE

K-Number: K852344 · 1985-07-01

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1985-07-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DISTALITE POSTERIA 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 1985-07-01 under 510(k) number K852344. 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 DISTALITE POSTERIA DENTAL RESTORATIVE?

DISTALITE POSTERIA DENTAL RESTORATIVE is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K852344.

When did DISTALITE POSTERIA DENTAL RESTORATIVE receive FDA 510(k) clearance?

DISTALITE POSTERIA DENTAL RESTORATIVE received FDA 510(k) clearance on 1985-07-01, under 510(k) number K852344.

Who is the listed applicant for DISTALITE POSTERIA 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 DISTALITE POSTERIA DENTAL RESTORATIVE?

The FDA product code for DISTALITE POSTERIA DENTAL RESTORATIVE is EBF.

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Related Devices (Code: EBF)

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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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