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FDA 510(k)

KERR HARD DENTURE RELINE MATERIAL

K-Number: K981448 · 1998-06-16

ApplicantSybron Dental Specialties, Inc.
Decision Date1998-06-16
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERR HARD DENTURE RELINE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1998-06-16 under 510(k) number K981448. 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 KERR HARD DENTURE RELINE MATERIAL?

KERR HARD DENTURE RELINE MATERIAL is a medical device that received FDA 510(k) clearance on 1998-06-16. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K981448.

When did KERR HARD DENTURE RELINE MATERIAL receive FDA 510(k) clearance?

KERR HARD DENTURE RELINE MATERIAL received FDA 510(k) clearance on 1998-06-16, under 510(k) number K981448.

Who is the listed applicant for KERR HARD DENTURE RELINE MATERIAL?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERR HARD DENTURE RELINE MATERIAL?

The FDA product code for KERR HARD DENTURE RELINE MATERIAL is EBI.

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Related Devices (Code: 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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