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FDA 510(k)

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL

K-Number: K864709 · 1987-02-10

ApplicantIvoclar USA, Inc.
Decision Date1987-02-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar USA, Inc.. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K864709. 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 IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL?

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K864709.

When did IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL receive FDA 510(k) clearance?

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL received FDA 510(k) clearance on 1987-02-10, under 510(k) number K864709.

Who is the listed applicant for IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL?

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

What is the FDA product code for IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL?

The FDA product code for IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL is EBI.

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Other records listing Ivoclar USA, 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.

K012877HIGH GOLD PALLADIUM FREE CERAMIC SOLDERK981264ARISTON PHCK980986PROCADK941849PROVIPONT C&BK923644DW243-64K864708SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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