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FDA 510(k)

CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG

K-Number: K964038 · 1997-04-02

ApplicantHeraeus Kulzer, Inc.
Decision Date1997-04-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K964038. 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 CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG?

CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K964038.

When did CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG receive FDA 510(k) clearance?

CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG received FDA 510(k) clearance on 1997-04-02, under 510(k) number K964038.

Who is the listed applicant for CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG?

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

What is the FDA product code for CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG?

The FDA product code for CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG is KLE.

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Other records listing Heraeus Kulzer, 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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