Product code MYB— Dental

FDA has cleared 6 devices under product code MYB between 1999 and 2018, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20181 clearance
• 20141 clearance
• 20101 clearance
• 20041 clearance
• 20021 clearance
• 19991 clearance

• Sleep Specialists, LLC1 clearance
• Sleep Devices, Inc.1 clearance
• Nightbalance BV1 clearance
• Lifesleep Systems, Inc.1 clearance
• Aeolus International Corporation1 clearance
• Advanced Brain Monitoring, Inc.1 clearance

• K180608 — Lunoa SystemNightbalance BV·2018-06-05
• K140190 — NIGHT SHIFTAdvanced Brain Monitoring, Inc.·2014-05-29
• K100160 — ZZOMA POSITIONAL SLEEPER MODEL 001Sleep Specialists, LLC·2010-05-11
• K040161 — SONA PILLOWSleep Devices, Inc.·2004-04-30
• K023010 — SNIFF POSITION PILLOWS/POPITZ PILLOWSAeolus International Corporation·2002-10-01
• K990871 — PILLOWPOSITIVE CERVICAL PILLOWLifesleep Systems, Inc.·1999-06-10