Product code ECI— Dental

FDA has cleared 25 devices under product code ECI between 1978 and 1998, filed by 15 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.

• 19982 clearances
• 19971 clearance
• 19954 clearances
• 19943 clearances
• 19937 clearances
• 19881 clearance
• 19855 clearances
• 19811 clearance
• 19781 clearance

• A Company, Inc.5 clearances
• Jon-Ko Products, Inc.4 clearances
• Glenroe Technologies3 clearances
• Unitek Corp.2 clearances
• Professional Positioners, Inc.1 clearance
• Ortho Kinetics Corp.1 clearance
• Orec Corp.1 clearance
• Nexadental1 clearance
• Hygienic Dental Mfg., Co., The1 clearance
• Glenroe Technologies, Inc.1 clearance

• K980864 — POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.·1998-04-20
• K980053 — GLENROE CHAINGlenroe Technologies·1998-02-24
• K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroe·1997-12-01
• K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.·1995-05-24
• K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, Inc.·1995-05-23
• K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.·1995-05-23
• K943420 — ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.·1995-05-23
• K940165 — ALASTIKUnitek Corp.·1994-03-07
• K932298 — PRO'S NEO-LASTICSProfessional Positioners, Inc.·1994-02-14
• K935144 — DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICSDentauraum, Inc.·1994-02-04
• K932319 — ORTHODONTIC ELASTOMERGac Intl., Inc.·1993-09-20
• K931462 — GLENROE CHAINGlenroe Technologies, Inc.·1993-07-22
• K923999 — ALASTIK NSUnitek Corp.·1993-06-24
• K930453 — SINGLESNexadental·1993-05-27
• K924140 — TUFF TIESGlenroe Technologies·1993-04-27
• K924139 — GLENROE ORTHO SEPSGlenroe Technologies·1993-04-08
• K926578 — UNI-STICK PLASTIC LIGATURE, MODIFIEDAmerican Orthodontics·1993-03-31
• K882695 — RUBBER BAND, STERILEBioseal·1988-10-13
• K852596 — A-COMPANY ELASTIC LIGATURE RINGSA Company, Inc.·1985-07-31
• K852597 — A-COMPANY ELASTIC ROTATION WEDGESA Company, Inc.·1985-07-31
• K852598 — A-COMPANY SEPARATING ELASTICSA Company, Inc.·1985-07-31
• K852599 — A-COMPANY ELASTOMERIC TUBINGA Company, Inc.·1985-07-31
• K852600 — A-COMPANY ELASTOMERIC CHAIN DISPENSERA Company, Inc.·1985-07-31
• K810010 — ORTHODONTIC ELASTICSOrec Corp.·1981-01-28
• K780804 — HYGIENIC ANCHORINGSHygienic Dental Mfg., Co., The·1978-06-14