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FDA 510(k)

TEMP BOND CLEAR

K-Number: K972844 · 1997-10-03

ApplicantKerr Dental Materials Center
Decision Date1997-10-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMP BOND CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K972844. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMP BOND CLEAR?

TEMP BOND CLEAR is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K972844.

When did TEMP BOND CLEAR receive FDA 510(k) clearance?

TEMP BOND CLEAR received FDA 510(k) clearance on 1997-10-03, under 510(k) number K972844.

Who is the listed applicant for TEMP BOND CLEAR?

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

What is the FDA product code for TEMP BOND CLEAR?

The FDA product code for TEMP BOND CLEAR is EMA.

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Other records listing Kerr Dental Materials Center 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.

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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