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FDA 510(k)

JUELL HARD CURE

K-Number: K111177 · 2011-09-12

ApplicantJuell Dental
Decision Date2011-09-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JUELL HARD CURE is the device name listed in this FDA 510(k) record. The listed applicant is Juell Dental. It received FDA 510(k) clearance on 2011-09-12 under 510(k) number K111177. 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 JUELL HARD CURE?

JUELL HARD CURE is a medical device that received FDA 510(k) clearance on 2011-09-12. The listed applicant is Juell Dental. The 510(k) number is K111177.

When did JUELL HARD CURE receive FDA 510(k) clearance?

JUELL HARD CURE received FDA 510(k) clearance on 2011-09-12, under 510(k) number K111177.

Who is the listed applicant for JUELL HARD CURE?

The FDA 510(k) record lists Juell Dental as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JUELL HARD CURE?

The FDA product code for JUELL HARD CURE is EBI.

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Other records listing Juell Dental 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.

K111178JUELL SOFT CUREK110548OSI O-BALL ABUTMENT HEAD IMPLANTS

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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