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FDA 510(k)

Yamahachi Pink CAD/CAM Disk

K-Number: K172683 · 2018-01-16

ApplicantYAMAHACHI DENTAL MFG., Co.
Decision Date2018-01-16
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Yamahachi Pink CAD/CAM Disk is the device name listed in this FDA 510(k) record. The listed applicant is YAMAHACHI DENTAL MFG., Co.. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K172683. 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 Pink CAD/CAM Disk?

Yamahachi Pink CAD/CAM Disk is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is YAMAHACHI DENTAL MFG., Co.. The 510(k) number is K172683.

When did Yamahachi Pink CAD/CAM Disk receive FDA 510(k) clearance?

Yamahachi Pink CAD/CAM Disk received FDA 510(k) clearance on 2018-01-16, under 510(k) number K172683.

Who is the listed applicant for Yamahachi Pink CAD/CAM Disk?

The FDA 510(k) record lists YAMAHACHI DENTAL MFG., Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yamahachi Pink CAD/CAM Disk?

The FDA product code for Yamahachi Pink CAD/CAM Disk is EBI.

Other records listing YAMAHACHI DENTAL MFG., Co. 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.

K254091GLOSSY COAT (15ML)K233859BASIS FLOW II

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.

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.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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