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FDA 510(k)

KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI

K-Number: K844662 · 1985-03-25

ApplicantKerr Corporation (Danbury)
Decision Date1985-03-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K844662. 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 KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI?

KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K844662.

When did KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI receive FDA 510(k) clearance?

KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI received FDA 510(k) clearance on 1985-03-25, under 510(k) number K844662.

Who is the listed applicant for KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI?

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

What is the FDA product code for KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI?

The FDA product code for KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI is EBF.

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Other records listing Kerr Corporation (Danbury) 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.

K051545L.E. DEMETRON IIK020091OPTILUX 501K951663TYTIN RK951511TYTIN ADMIXK942480M4 CONTRA-ANGLE HANDPIECEK940513OPTIBOND

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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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