Home › Device types › EFB
Handpiece, Air-Powered, Dental
FDA product code EFB · Class 1 · Dental
2,866
Registered devices
2,300
Adverse events
8
Recalls
263
510(k) clearances
Devices with this code
StarDental Instrument Solutions — DENTALEZ, INC.Ti-MU03 — NAKANISHI INC.WP-64 M Proxeo — W & H Dentalwerk Bürmoos GmbHLares Research — LARES RESEARCHCA 20:1L Micro-Series — Bien-Air Dental SAMidwest Low Speed Attachment — SIRONA Dental Systems GmbHVector R&D, Inc — Vector R&D, Inc.SCHICK — SIRONA DENTAL, INC.XIOS — SIRONA DENTAL, INC.SABLE - Doctor's Package — Sable Industries IncSet Aquilon830 IR C + Unifix 4H — Bien-Air Dental SAINTRA Endo Kopf L3 Y — KaVo Dental GmbHwenjian — Foshan Wenjian Medical Instrument Co., Ltd.PTL-CL-FV-T — NAKANISHI INC.QUALITY PLUS — HANDPIECE PARTS & REPAIRS, INC.MEDIDENTA — HANDPIECE PARTS & REPAIRS, INC.TK-97 LM Synea Vision — W & H Dentalwerk Bürmoos GmbHPerio-Mate — NAKANISHI INC.StarDental Instrument Solutions — DENTALEZ, INC.COUPLING UNIFIX 4H US — BIEN-AIR PORTUGAL, UNIPESSOAL, LDAHOSE 4 HOLE L M 10 GREY B — BIEN-AIR PORTUGAL, UNIPESSOAL, LDAMicroP Dental — MICROP TECHNOLOGY (TAIWAN) INC.INTRA EVA Kopf L61 R — KaVo Dental GmbHLares 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.