FDA 510(k)

EVO 450系列高速手柄

K号: K190508 · 2019-12-11

决定日期2019-12-11

产品代码EFB

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决定实质等同

器械摘要

EVO 450 series High Speed Handpieces is the device name listed in this FDA 510(k) record. The listed applicant is Ttbio Corp.. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K190508. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EVO 450 series High Speed Handpieces?

EVO 450 series High Speed Handpieces is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Ttbio Corp.. The 510(k) number is K190508.

When did EVO 450 series High Speed Handpieces receive FDA 510(k) clearance?

EVO 450 series High Speed Handpieces received FDA 510(k) clearance on 2019-12-11, under 510(k) number K190508.

Who is the listed applicant for EVO 450 series High Speed Handpieces?

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

What is the FDA product code for EVO 450 series High Speed Handpieces?

The FDA product code for EVO 450 series High Speed Handpieces is EFB.

列明Ttbio Corp.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232243EVO 700系列高速手柄 K210832EVOCLEAN CLEANsert 超声探头 K201317TTBIO EVOCLEAN 超声波洁牙器

相关器械（代码：EFB）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262144DIAMED 手柄；DIAMED 空气电机；DIAMED 空气电机手柄SETAGAYA SEIKI Co., Ltd.K251389高速空气涡轮手柄Foshan Topmed Dental Co., Ltd.K251388牙科气动电机手柄 (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.K242179Synea 融合手柄（Intensiv & Profin）W&H Dentalwerk Bürmoos GmbH K240337牙科手柄（型号：J6-126，J6-136，SH11W2，SH11W3，W401LW，W15LW，W142LW，W11L）Guangdong Jinme Medical Technology Co., Ltd.K241074高速空气涡轮手柄（SCHG01，SCHG03，SCHG18，SCHF19，SCHF22），包括直角和齿轮角度手柄以及空气电机（直角手柄：SCHD05-S，SCHD16-S，SCHD17-S，SCHD24-S，SCHD27-S 齿轮角度手柄：SCHD05-C，SCHD06-C，SCHD16-C，SCHD17-C，SCHD24-C，SCHD27-C，SCHD29-S，SCHB4，SCHB5，SCHB20，SCHB64 空气电机：SCHD16-M，SCHD17-M，SCHD24-M，SCHD27-M）Foshan Soco Precision Instrument Co., Ltd.

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