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FDA 510(k)

DC-CORE

K-Number: K984097 · 1999-02-09

ApplicantS & C Polymer GmbH
Decision Date1999-02-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DC-CORE is the device name listed in this FDA 510(k) record. The listed applicant is S & C Polymer GmbH. It received FDA 510(k) clearance on 1999-02-09 under 510(k) number K984097. 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 DC-CORE?

DC-CORE is a medical device that received FDA 510(k) clearance on 1999-02-09. The listed applicant is S & C Polymer GmbH. The 510(k) number is K984097.

When did DC-CORE receive FDA 510(k) clearance?

DC-CORE received FDA 510(k) clearance on 1999-02-09, under 510(k) number K984097.

Who is the listed applicant for DC-CORE?

The FDA 510(k) record lists S & C Polymer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC-CORE?

The FDA product code for DC-CORE is EBF.

Other records listing S & C Polymer GmbH 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.

K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTK083062ROOT CANAL XRK083766PHOGLASS CEMK082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTK081702CARBOXYLATE CEM, PHOSPHATE CEMK042614S&C-SELF ETCH PR-BOND

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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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