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FDA 510(k)

CHARISMA SUPERLIGHT

K-Number: K935736 · 1994-01-26

ApplicantHeraeus Kulzer, Inc.
Decision Date1994-01-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHARISMA SUPERLIGHT 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 1994-01-26 under 510(k) number K935736. 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 CHARISMA SUPERLIGHT?

CHARISMA SUPERLIGHT is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K935736.

When did CHARISMA SUPERLIGHT receive FDA 510(k) clearance?

CHARISMA SUPERLIGHT received FDA 510(k) clearance on 1994-01-26, under 510(k) number K935736.

Who is the listed applicant for CHARISMA SUPERLIGHT?

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 SUPERLIGHT?

The FDA product code for CHARISMA SUPERLIGHT is EBF.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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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