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FDA 510(k)

PROBASE HOT AND PROBASE COLD

K-Number: K913655 · 1991-10-17

ApplicantIvoclar North America, Inc.
Decision Date1991-10-17
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROBASE HOT AND PROBASE COLD is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1991-10-17 under 510(k) number K913655. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROBASE HOT AND PROBASE COLD?

PROBASE HOT AND PROBASE COLD is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K913655.

When did PROBASE HOT AND PROBASE COLD receive FDA 510(k) clearance?

PROBASE HOT AND PROBASE COLD received FDA 510(k) clearance on 1991-10-17, under 510(k) number K913655.

Who is the listed applicant for PROBASE HOT AND PROBASE COLD?

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

What is the FDA product code for PROBASE HOT AND PROBASE COLD?

The FDA product code for PROBASE HOT AND PROBASE COLD is EBI.

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Other records listing Ivoclar North America, Inc. as applicant

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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