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FDA 510(k)

MAJOR.REPAIR

K-Number: K082153 · 2008-11-25

ApplicantMajor Prodotti Dentari S.P.A.
Decision Date2008-11-25
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAJOR.REPAIR is the device name listed in this FDA 510(k) record. The listed applicant is Major Prodotti Dentari S.P.A.. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K082153. 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 MAJOR.REPAIR?

MAJOR.REPAIR is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Major Prodotti Dentari S.P.A.. The 510(k) number is K082153.

When did MAJOR.REPAIR receive FDA 510(k) clearance?

MAJOR.REPAIR received FDA 510(k) clearance on 2008-11-25, under 510(k) number K082153.

Who is the listed applicant for MAJOR.REPAIR?

The FDA 510(k) record lists Major Prodotti Dentari S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAJOR.REPAIR?

The FDA product code for MAJOR.REPAIR is EBI.

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Other records listing Major Prodotti Dentari S.P.A. 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.

K082700TEMPORARY COLD.V AND SELF-CURE DENTINEK081884MAJOR.BASE 20

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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