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FDA 510(k)

OPAKER

K-Number: K955337 · 1996-01-23

ApplicantKerr Dental Materials Center
Decision Date1996-01-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPAKER 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 1996-01-23 under 510(k) number K955337. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPAKER?

OPAKER is a medical device that received FDA 510(k) clearance on 1996-01-23. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K955337.

When did OPAKER receive FDA 510(k) clearance?

OPAKER received FDA 510(k) clearance on 1996-01-23, under 510(k) number K955337.

Who is the listed applicant for OPAKER?

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 OPAKER?

The FDA product code for OPAKER is EBF.

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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.

K050984BIOPLANTK031444OPTIBOND FLK030646BELLEGLASS POINT 4K020303XR PRIMER 2K020178BELLEGLASS HP MODELING GELK020092TEMPHASE

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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