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FDA 510(k)

HELIOSEAL CLEAR CHROMA

K-Number: K011491 · 2001-08-16

ApplicantIvoclar North America, Inc.
Decision Date2001-08-16
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIOSEAL CLEAR CHROMA 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 2001-08-16 under 510(k) number K011491. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOSEAL CLEAR CHROMA?

HELIOSEAL CLEAR CHROMA is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K011491.

When did HELIOSEAL CLEAR CHROMA receive FDA 510(k) clearance?

HELIOSEAL CLEAR CHROMA received FDA 510(k) clearance on 2001-08-16, under 510(k) number K011491.

Who is the listed applicant for HELIOSEAL CLEAR CHROMA?

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 HELIOSEAL CLEAR CHROMA?

The FDA product code for HELIOSEAL CLEAR CHROMA is EBC.

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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.

K012174ERIS LAYERING MATERIALSK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDFK010381D.SIGN 30

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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