Home › Device types › ECI
Band, Elastic, Orthodontic
FDA product code ECI · Class 1 · Dental
7,962
Registered devices
18
Adverse events
3
Recalls
25
510(k) clearances
Devices with this code
Phoenix Elastics — PHOENIX ORTHODONTICS INCORTHOFLEXY ELASTOMERIC - CHAIN 4.5M - SHORT (.136") - PEARL BLUE — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANA — G & H Wire Company, Inc.E-Chain — TP ORTHODONTICS INCAURADONICS — AURADONICS INC.PHOENIX — AURADONICS INC.MIRABAY — Mirabay Orthodontics Corp.Colored Chain — AMERICAN ORTHODONTICS CORPORATIONCONLIN MOLAR BAND — Ortho Arch Company IncPHOENIX — AURADONICS INC.EXTRA-ORAL ELASTIC 16 OZ 1/2" NO MINT FLAVOR — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDALEONE SPA — LEONE SPAAdvance Dental Products — The Atlanta Dental Supply CompanyELASTOMERIC CHAIN ORTHOMETRIC - 4,5M - MEDIUM - CORAL — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAORTHOFLEXY ELASTOMERIC - MODULAR LIGATURE 22 TIES - BABY BLUE — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAREGULAR GLIDE-TIES — Ortho Arch Company IncNA — G & H Wire Company, Inc.Morelli — Dental Morelli LtdaHenry Schein — HENRY SCHEIN, INC.Masel — Ortho Organizers, Inc.Elastic Chain — Ortho Organizers, Inc.Elastic Thread — Ortho Organizers, Inc.Maximum™ — ORTHO TECHNOLOGY, INC.E-Links Modules — TP ORTHODONTICS INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-21 | G & H Wire Company | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy |
| 2021-01-21 | G & H Wire Company | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity f |
| 2011-08-18 | Biomet Microfixation, Inc. | On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although |
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