FDA Device Intelligence
HomeDevice types › EFA

Handpiece, Belt And/Or Gear Driven, Dental

FDA product code EFA · Class 1 · Dental

195
Registered devices
220
Adverse events
3
Recalls
25
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2014-06-13Dental EZ Group Star Dental DivisionThe housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
2010-08-11Dental EZ Stardental DivisionThe housing of 5K motor is labeled as a 20K motor.
2006-12-01Stardental DivisionEnd cap component can disassemble.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.