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FDA 510(k)

PANA SPRAY PLUS

K-Number: K131014 · 2013-08-12

ApplicantNsk America Corp.
Decision Date2013-08-12
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANA SPRAY PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Nsk America Corp.. It received FDA 510(k) clearance on 2013-08-12 under 510(k) number K131014. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANA SPRAY PLUS?

PANA SPRAY PLUS is a medical device that received FDA 510(k) clearance on 2013-08-12. The listed applicant is Nsk America Corp.. The 510(k) number is K131014.

When did PANA SPRAY PLUS receive FDA 510(k) clearance?

PANA SPRAY PLUS received FDA 510(k) clearance on 2013-08-12, under 510(k) number K131014.

Who is the listed applicant for PANA SPRAY PLUS?

The FDA 510(k) record lists Nsk America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANA SPRAY PLUS?

The FDA product code for PANA SPRAY PLUS is EFB.

Related Clinical Trials

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.

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Other records listing Nsk America Corp. 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.

K052700PANA-SPRAY

Related Devices (Code: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

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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