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FDA 510(k)

YAMAHACHI DENTURE BASE RESINS

K-Number: K131036 · 2013-07-12

ApplicantYamahachi Dental Manufacturing Co.
Decision Date2013-07-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

YAMAHACHI DENTURE BASE RESINS is the device name listed in this FDA 510(k) record. The listed applicant is Yamahachi Dental Manufacturing Co.. It received FDA 510(k) clearance on 2013-07-12 under 510(k) number K131036. 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 YAMAHACHI DENTURE BASE RESINS?

YAMAHACHI DENTURE BASE RESINS is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Yamahachi Dental Manufacturing Co.. The 510(k) number is K131036.

When did YAMAHACHI DENTURE BASE RESINS receive FDA 510(k) clearance?

YAMAHACHI DENTURE BASE RESINS received FDA 510(k) clearance on 2013-07-12, under 510(k) number K131036.

Who is the listed applicant for YAMAHACHI DENTURE BASE RESINS?

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

What is the FDA product code for YAMAHACHI DENTURE BASE RESINS?

The FDA product code for YAMAHACHI DENTURE BASE RESINS is EBI.

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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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