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FDA 510(k)

ROOT CANAL XR

K-Number: K083062 · 2009-03-12

ApplicantS & C Polymer GmbH
Decision Date2009-03-12
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL XR 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 2009-03-12 under 510(k) number K083062. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT CANAL XR?

ROOT CANAL XR is a medical device that received FDA 510(k) clearance on 2009-03-12. The listed applicant is S & C Polymer GmbH. The 510(k) number is K083062.

When did ROOT CANAL XR receive FDA 510(k) clearance?

ROOT CANAL XR received FDA 510(k) clearance on 2009-03-12, under 510(k) number K083062.

Who is the listed applicant for ROOT CANAL XR?

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 ROOT CANAL XR?

The FDA product code for ROOT CANAL XR is KIF.

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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, IMPLANTK083766PHOGLASS CEMK082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTK081702CARBOXYLATE CEM, PHOSPHATE CEMK042614S&C-SELF ETCH PR-BONDK031420S & C -BRACKET ADHESIVES

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Related Devices (Code: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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