Product code EFN— Dental

FDA has cleared 14 devices under product code EFN between 1977 and 1987, filed by 13 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.

• 19872 clearances
• 19863 clearances
• 19851 clearance
• 19842 clearances
• 19831 clearance
• 19812 clearances
• 19801 clearance
• 19791 clearance
• 19771 clearance

• Intl. Verbandstoff-Fabrik Schaffhau2 clearances
• Worldwide Surgical Gauze1 clearance
• Veratex Corp.1 clearance
• The Medical Group, Inc.1 clearance
• Parker Laboratories, Inc.1 clearance
• Molnlycke A/S Hospital Products1 clearance
• Medspec Corp.1 clearance
• Medgroup Enterprises, Inc.1 clearance
• Lorvic Corp.1 clearance
• Hoyt Laboratories1 clearance

• K872810 — STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.·1987-12-04
• K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STERMedgroup Enterprises, Inc.·1987-04-30
• K863764 — COTTON ROLLS, NON-STERILEThe Medical Group, Inc.·1986-10-27
• K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILEIntl. Verbandstoff-Fabrik Schaffhau·1986-08-06
• K861727 — COTTON FILLED GAUZE SPONGES 2 X 2Cross Country Paper Products Corp.·1986-07-10
• K843539 — TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital Products·1985-05-23
• K841327 — DENTAL COTTON ROLLSIntl. Verbandstoff-Fabrik Schaffhau·1984-07-03
• K834056 — SCHEIN COTTON ROLLS, NON-STERILEHenry Schein, Inc.·1984-02-03
• K830175 — STERILE COTTON ROLLS #3, 1 1/2Veratex Corp.·1983-02-18
• K812709 — STERILE DENTAL ROLLMedspec Corp.·1981-10-23
• K810830 — HOYT COTTON ROLLSHoyt Laboratories·1981-04-14
• K802429 — COTTON ROLLSWorldwide Surgical Gauze·1980-10-23
• K792391 — COTTON ROLL COMPRESSION CAPSParker Laboratories, Inc.·1979-12-06
• K770063 — DISP. ABSORBENT COMPRESSED FIBRE WAFERLorvic Corp.·1977-01-14