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FDA 510(k)

FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL

K-Number: K934978 · 1993-12-10

ApplicantIvoclar North America, Inc.
Decision Date1993-12-10
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL 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 1993-12-10 under 510(k) number K934978. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL?

FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K934978.

When did FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL receive FDA 510(k) clearance?

FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL received FDA 510(k) clearance on 1993-12-10, under 510(k) number K934978.

Who is the listed applicant for FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL?

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 FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL?

The FDA product code for FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL is EBG.

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Other records listing Ivoclar North America, Inc. as applicant

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Related Devices (Code: EBG)

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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