Product code DYJ— Dental

FDA has cleared 5 devices under product code DYJ between 1984 and 1997, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19971 clearance
• 19941 clearance
• 19931 clearance
• 19911 clearance
• 19841 clearance

• Forestadent1 clearance
• Dentauraum, Inc.1 clearance
• Cleft Palate Appliances, Inc.1 clearance
• American Orthodontics1 clearance
• A Company, Inc.1 clearance

• K970930 — BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCECleft Palate Appliances, Inc.·1997-04-23
• K935154 — DENTAURUM EXPANSION SCREWSDentauraum, Inc.·1994-02-03
• K925088 — EXPANSION SCREWSForestadent·1993-05-22
• K912417 — MOLAR DISTALIZING ASSEMBLYAmerican Orthodontics·1991-12-20
• K843705 — MANDIBULATOR JAW POSITIONERA Company, Inc.·1984-11-14