Product code EFH— Dental

FDA has cleared 10 devices under product code EFH between 1977 and 1997, filed by 9 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
• 19921 clearance
• 19911 clearance
• 19872 clearances
• 19842 clearances
• 19811 clearance
• 19772 clearances

• Pascal Co., Inc.2 clearances
• Wallace A. Erickson & Co.1 clearance
• Sentek, Inc.1 clearance
• Prodent Intl., Inc.1 clearance
• Pfingst & Co., Inc.1 clearance
• Parker Laboratories, Inc.1 clearance
• Myo-Tronics Research, Inc.1 clearance
• Dey-Mat, Inc.1 clearance
• Ardent Intl., Inc.1 clearance

• K965026 — PFINGST PRESSURE PASTEPfingst & Co., Inc.·1997-02-10
• K912632 — OCCLUDEPascal Co., Inc.·1992-01-17
• K911259 — HYDENTPascal Co., Inc.·1991-06-06
• K864572 — FIXTECTORProdent Intl., Inc.·1987-02-12
• K870032 — REVISED T-SCAN SYSTEMSentek, Inc.·1987-02-02
• K832647 — ARTICULATING PAPERArdent Intl., Inc.·1984-02-21
• K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAYMyo-Tronics Research, Inc.·1984-02-10
• K810498 — CENTRIC (BITE) REGISTRATION PASTEWallace A. Erickson & Co.·1981-03-17
• K771011 — ARTICULATING PAPERParker Laboratories, Inc.·1977-06-20
• K770492 — CRACK DETECTOR, DEN-MATDey-Mat, Inc.·1977-03-21