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FDA 510(k)

PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM

K-Number: K960696 · 1996-07-18

ApplicantUltradent Products, Inc.
Decision Date1996-07-18
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K960696. 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 PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM?

PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K960696.

When did PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM receive FDA 510(k) clearance?

PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM received FDA 510(k) clearance on 1996-07-18, under 510(k) number K960696.

Who is the listed applicant for PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM?

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

What is the FDA product code for PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM?

The FDA product code for PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM is KLE.

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Related Devices (Code: KLE)

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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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