Home › Device types › EFB
Handpiece, Air-Powered, Dental
FDA product code EFB · Class 1 · Dental
2,851
Registered devices
2,071
Adverse events
8
Recalls
261
510(k) clearances
Devices with this code
Airlight — Beyes Dental Canada IncAir-Driven Dental Handpieces — MDK CO., LTD.Lynx Pro — LARES RESEARCHMidwest Low Speed Attachment — SIRONA Dental Systems GmbHPerio Mate Nozzle Tip — NAKANISHI INC.PM 1:2 — Bien-Air Dental SASX-PU03 — NAKANISHI INC.StarDental Instrument Solutions — DENTALEZ, INC.Henry Schein — HENRY SCHEIN, INC.EndoREZ — ULTRADENT PRODUCTS, INC.AIR-FLOW — E.M.S. Electro Medical Systems S.A.Vector R&D, Inc — Vector R&D, Inc.Brasseler USA — Peter Brasseler Holdings, LLCMK-dent Germany® — MK-Dent GmbHStarDental Instrument Solutions — DENTALEZ, INC.DELTON® — Dentsply ProfessionalMULTIflex Coupling 465 RN — KaVo Dental GmbHHenry Schein — HENRY SCHEIN, INC.Flight Dental Systems — Flight Dental SystemsMidwest Tradition® — SIRONA Dental Systems GmbHJohnson-Promident — Young Innovations, Inc.HE-43 XT Alegra handpiece 1:1 — W & H Dentalwerk Bürmoos GmbHF-Type Adaptor — NAKANISHI INC.Lares Research — LARES RESEARCH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-20 | Coltene Whaledent Inc | Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor t |
| 2012-05-07 | MTI Precision Products LLC. | Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. |
| 2006-11-22 | Kavo America Corporation | The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, th |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
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