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FDA 510(k)

SILKLINE SOFT RELINING KIT, MODEL 28-100100

K-Number: K060844 · 2006-06-06

ApplicantJ. Morita USA, Inc.
Decision Date2006-06-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILKLINE SOFT RELINING KIT, MODEL 28-100100 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K060844. 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 SILKLINE SOFT RELINING KIT, MODEL 28-100100?

SILKLINE SOFT RELINING KIT, MODEL 28-100100 is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K060844.

When did SILKLINE SOFT RELINING KIT, MODEL 28-100100 receive FDA 510(k) clearance?

SILKLINE SOFT RELINING KIT, MODEL 28-100100 received FDA 510(k) clearance on 2006-06-06, under 510(k) number K060844.

Who is the listed applicant for SILKLINE SOFT RELINING KIT, MODEL 28-100100?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILKLINE SOFT RELINING KIT, MODEL 28-100100?

The FDA product code for SILKLINE SOFT RELINING KIT, MODEL 28-100100 is EBI.

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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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