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Sources: EU EUDAMED, US FDA
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Country: Japan
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Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
SB-KAWASUMI LABORATORIES, INC.
Manufacturer
🇯🇵 Japan·408 Basic UDI-DIs·426 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
TOP Corporation
Manufacturer
🇯🇵 Japan·39 Basic UDI-DIs·97 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
TOP NEUROPOLE NEEDLE XE-PRF 20G 150-15mm
Device
EU MDR
·
Eu Md Class 2a
·TOP Corporation·On the market·7 countries
TOP NEUROPOLE NEEDLE SCCBL 20G 100-10mm
Device
EU MDR
·
Eu Md Class 2a
·TOP Corporation·On the market·5 countries
TOP NEUROPOLE NEEDLE SCCBL 20G 145-10mm
Device
EU MDR
·
Eu Md Class 2a
·TOP Corporation·On the market·5 countries
TOP Spinal Needle18G x 89mm
Device
EU MDD
·
Eu Md Class 3
·TOP Corporation·No longer on the market
PuraStat Nozzle System Type L
Device
EU MDD
·
Eu Md Class 2a
·TOP Corporation·On the market·2 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries
ARTERIOVENOUS FISTULA NEEDLES
Device
EU MDD
·
Eu Md Class 2a
·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries