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FDA 510(k)

ELAN-2

K-Number: K983091 · 1998-10-28

ApplicantKerr Dental Materials Center
Decision Date1998-10-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELAN-2 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 1998-10-28 under 510(k) number K983091. 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 ELAN-2?

ELAN-2 is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K983091.

When did ELAN-2 receive FDA 510(k) clearance?

ELAN-2 received FDA 510(k) clearance on 1998-10-28, under 510(k) number K983091.

Who is the listed applicant for ELAN-2?

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 ELAN-2?

The FDA product code for ELAN-2 is EBF.

Other records listing Kerr Dental Materials Center as applicant

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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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