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FDA 510(k)

HYBRID RESIN COMPOSITE

K-Number: K964867 · 1997-04-11

ApplicantParkell, Inc.
Decision Date1997-04-11
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYBRID RESIN COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1997-04-11 under 510(k) number K964867. 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 HYBRID RESIN COMPOSITE?

HYBRID RESIN COMPOSITE is a medical device that received FDA 510(k) clearance on 1997-04-11. The listed applicant is Parkell, Inc.. The 510(k) number is K964867.

When did HYBRID RESIN COMPOSITE receive FDA 510(k) clearance?

HYBRID RESIN COMPOSITE received FDA 510(k) clearance on 1997-04-11, under 510(k) number K964867.

Who is the listed applicant for HYBRID RESIN COMPOSITE?

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

What is the FDA product code for HYBRID RESIN COMPOSITE?

The FDA product code for HYBRID RESIN COMPOSITE is KLE.

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Other records listing Parkell, Inc. as applicant

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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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