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FDA 510(k)

SOFRELINER TOUGH S

K-Number: K112445 · 2011-10-28

ApplicantTokuyama Dental Corporation
Decision Date2011-10-28
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOFRELINER TOUGH S is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2011-10-28 under 510(k) number K112445. 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 SOFRELINER TOUGH S?

SOFRELINER TOUGH S is a medical device that received FDA 510(k) clearance on 2011-10-28. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K112445.

When did SOFRELINER TOUGH S receive FDA 510(k) clearance?

SOFRELINER TOUGH S received FDA 510(k) clearance on 2011-10-28, under 510(k) number K112445.

Who is the listed applicant for SOFRELINER TOUGH S?

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

What is the FDA product code for SOFRELINER TOUGH S?

The FDA product code for SOFRELINER TOUGH S is EBI.

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Other records listing Tokuyama Dental Corporation as applicant

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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.

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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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