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FDA 510(k)

ULTRACAL XS

K-Number: K970114 · 1997-03-14

ApplicantUltradent Products, Inc.
Decision Date1997-03-14
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRACAL XS 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 1997-03-14 under 510(k) number K970114. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACAL XS?

ULTRACAL XS is a medical device that received FDA 510(k) clearance on 1997-03-14. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K970114.

When did ULTRACAL XS receive FDA 510(k) clearance?

ULTRACAL XS received FDA 510(k) clearance on 1997-03-14, under 510(k) number K970114.

Who is the listed applicant for ULTRACAL XS?

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 ULTRACAL XS?

The FDA product code for ULTRACAL XS is EJK.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: EJK)

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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