FDA 510(k)

BioSonic US200超声波洁牙器（60034537）

K号: K240801 · 2024-07-01

决定日期2024-07-01

产品代码ELC

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决定实质等同

器械摘要

BioSonic US200 Ultrasonic Scaler (60034537) is the device name listed in this FDA 510(k) record. The listed applicant is Dent4you AG. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K240801. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioSonic US200 Ultrasonic Scaler (60034537)?

BioSonic US200 Ultrasonic Scaler (60034537) is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Dent4you AG. The 510(k) number is K240801.

When did BioSonic US200 Ultrasonic Scaler (60034537) receive FDA 510(k) clearance?

BioSonic US200 Ultrasonic Scaler (60034537) received FDA 510(k) clearance on 2024-07-01, under 510(k) number K240801.

Who is the listed applicant for BioSonic US200 Ultrasonic Scaler (60034537)?

The FDA 510(k) record lists Dent4you AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSonic US200 Ultrasonic Scaler (60034537)?

The FDA product code for BioSonic US200 Ultrasonic Scaler (60034537) is ELC.

列明Dent4you AG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。

K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST K242360Speedex 轻型体；Speedex 中型；Speedex 灰泥；Speedex 灰泥软；Speedex 通用激活器 K223142Coltolux Comfort LED Curing Light

相关器械（代码：ELC）

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。

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A K251689VARIOS 170 LUX 放大镜系统（VA170LUXS10）；VARIOS 170 LUX 放大镜系统（VA170LUXS11）；VARIOS 170 放大镜系统（VA170S11）Nakanishi, Inc.K242317集成式内窥镜系统（Meet Endo-II）Denjoy Dental Co., Ltd.K233844OdneCleanOdne AG K240707超声波洁牙器（WD-JY-B002，WD-JY-W001，WD-JY-R003，WD-JY-G004，WD-JY-B003，WD-JY-C006，WD-JY-M0014，WD-JY-N0015，WD-JY-N0016，WD-JY-N0017，WD-JY-E007，WD-JY-F008，WD-JY-A005，WD-JY-H009，WD-JY-I0011，WD-JY-K0012，WD-JY-K0013，WD-JY-K0014，WD-JY-L0013，WD-JY-L0014，WD-JY-L0015，WD-JY-L0016，WD-JY-L0017）Shenzhen Micro Electric Intelligence Co., Ltd.

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