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FDA 510(k)

PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)

K-Number: K980616 · 1998-04-30

ApplicantKohler Medizintechnik GmbH & Co. KG
Decision Date1998-04-30
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) is the device name listed in this FDA 510(k) record. The listed applicant is Kohler Medizintechnik GmbH & Co. KG. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K980616. 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 PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)?

PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Kohler Medizintechnik GmbH & Co. KG. The 510(k) number is K980616.

When did PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) receive FDA 510(k) clearance?

PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) received FDA 510(k) clearance on 1998-04-30, under 510(k) number K980616.

Who is the listed applicant for PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)?

The FDA 510(k) record lists Kohler Medizintechnik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)?

The FDA product code for PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) 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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