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FDA 510(k)

AURAFILL* DENTAL RESTORATIVE BONDING AG.

K-Number: K822451 · 1982-09-07

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1982-09-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURAFILL* DENTAL RESTORATIVE BONDING AG. 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 1982-09-07 under 510(k) number K822451. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFILL* DENTAL RESTORATIVE BONDING AG.?

AURAFILL* DENTAL RESTORATIVE BONDING AG. is a medical device that received FDA 510(k) clearance on 1982-09-07. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K822451.

When did AURAFILL* DENTAL RESTORATIVE BONDING AG. receive FDA 510(k) clearance?

AURAFILL* DENTAL RESTORATIVE BONDING AG. received FDA 510(k) clearance on 1982-09-07, under 510(k) number K822451.

Who is the listed applicant for AURAFILL* DENTAL RESTORATIVE BONDING AG.?

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 AURAFILL* DENTAL RESTORATIVE BONDING AG.?

The FDA product code for AURAFILL* DENTAL RESTORATIVE BONDING AG. is KLE.

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Related Devices (Code: KLE)

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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