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FDA 510(k)

MIRADAPT* DENTAL RESTORATIVE

K-Number: K791318 · 1979-09-12

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1979-09-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIRADAPT* 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 1979-09-12 under 510(k) number K791318. 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 MIRADAPT* DENTAL RESTORATIVE?

MIRADAPT* DENTAL RESTORATIVE is a medical device that received FDA 510(k) clearance on 1979-09-12. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K791318.

When did MIRADAPT* DENTAL RESTORATIVE receive FDA 510(k) clearance?

MIRADAPT* DENTAL RESTORATIVE received FDA 510(k) clearance on 1979-09-12, under 510(k) number K791318.

Who is the listed applicant for MIRADAPT* 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 MIRADAPT* DENTAL RESTORATIVE?

The FDA product code for MIRADAPT* 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.

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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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