FDA 510(k)

EVO 700系列高速手柄

K号: K232243 · 2023-08-23

决定日期2023-08-23

产品代码EFB

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决定实质等同

器械摘要

EVO 700 series high speed handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Ttbio Corp.. It received FDA 510(k) clearance on 2023-08-23 under 510(k) number K232243. 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 700 series high speed handpiece?

EVO 700 series high speed handpiece is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Ttbio Corp.. The 510(k) number is K232243.

When did EVO 700 series high speed handpiece receive FDA 510(k) clearance?

EVO 700 series high speed handpiece received FDA 510(k) clearance on 2023-08-23, under 510(k) number K232243.

Who is the listed applicant for EVO 700 series high speed handpiece?

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 700 series high speed handpiece?

The FDA product code for EVO 700 series high speed handpiece 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。

K210832EVOCLEAN CLEANsert 超声探头 K201317TTBIO EVOCLEAN 超声波洁牙器 K190508EVO 450系列高速手柄

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.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.K251389高速空气涡轮手柄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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