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FDA 510(k)

DENTO-SURGE

K-Number: K955176 · 1996-04-15

ApplicantEllman Intl., Inc.
Decision Date1996-04-15
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTO-SURGE is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl., Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K955176. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTO-SURGE?

DENTO-SURGE is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K955176.

When did DENTO-SURGE receive FDA 510(k) clearance?

DENTO-SURGE received FDA 510(k) clearance on 1996-04-15, under 510(k) number K955176.

Who is the listed applicant for DENTO-SURGE?

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

What is the FDA product code for DENTO-SURGE?

The FDA product code for DENTO-SURGE is EKZ.

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Related Devices (Code: EKZ)

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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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