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FDA 510(k)

CAVIOS CAVITY LINER

K-Number: K111668 · 2011-08-19

ApplicantNeodental Chemical Products Co., Ltd.
Decision Date2011-08-19
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAVIOS CAVITY LINER is the device name listed in this FDA 510(k) record. The listed applicant is Neodental Chemical Products Co., Ltd.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111668. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVIOS CAVITY LINER?

CAVIOS CAVITY LINER is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Neodental Chemical Products Co., Ltd.. The 510(k) number is K111668.

When did CAVIOS CAVITY LINER receive FDA 510(k) clearance?

CAVIOS CAVITY LINER received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111668.

Who is the listed applicant for CAVIOS CAVITY LINER?

The FDA 510(k) record lists Neodental Chemical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAVIOS CAVITY LINER?

The FDA product code for CAVIOS CAVITY LINER is EJK.

Related Clinical Trials

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Other records listing Neodental Chemical Products Co., Ltd. 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.

K111666EVADYNE TEMPORARY CROWN AND BRIDGE RESINK973667VITAPEX PRE-LOADED DENTAL SYRINGEK971642DENTALIS KEZ ENDODONITC SEALERK955703NEO DENTAL ENDODONTIC IRRIGATION SYRINGE

Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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