Product code EAX— Dental

FDA has cleared 12 devices under product code EAX between 1980 and 1995, filed by 11 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.

• 19951 clearance
• 19943 clearances
• 19862 clearances
• 19842 clearances
• 19832 clearances
• 19821 clearance
• 19801 clearance

• The Medical Group, Inc.2 clearances
• Union Broach, Div. Moyco Industries, Inc.1 clearance
• Teledyne, Inc.1 clearance
• Ranir/Dcp Corp.1 clearance
• Pacific Dental Corp.1 clearance
• Hti, Inc.1 clearance
• Hines Group , Ltd.1 clearance
• Henry Schein, Inc.1 clearance
• Dentec, Inc.1 clearance
• Dentalsafe Systems Pty., Ltd.1 clearance

• K946073 — ORALVUE DENTAL MIRRORHines Group , Ltd.·1995-02-16
• K935906 — RANIR PLAX RXRanir/Dcp Corp.·1994-09-02
• K941574 — RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.·1994-05-18
• K935687 — NILDentalsafe Systems Pty., Ltd.·1994-02-03
• K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.·1986-10-30
• K863767 — GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.·1986-10-30
• K833310 — FOGCUTTER DENTAL MOUTH MIRRORHti, Inc.·1984-05-07
• K841199 — FIBERGLASS MOUTH MIRRORSHenry Schein, Inc.·1984-04-25
• K833429 — PERI MIRROR/SALIVA EJECTORDentec, Inc.·1983-12-22
• K830777 — ELECTRIC MOUTH MIRRORAlmore Intl., Inc.·1983-04-06
• K821777 — BEACH MOUTH MIRRORPacific Dental Corp.·1982-07-06
• K800919 — ORAVIEW BY WATER PIKTeledyne, Inc.·1980-05-08