Home › Device types › ECI
Band, Elastic, Orthodontic
FDA product code ECI · Class 1 · Dental
8,097
Registered devices
18
Adverse events
3
Recalls
25
510(k) clearances
Devices with this code
Henry Schein — HENRY SCHEIN, INC.ORTHOMETRIC ELASTOMERICS - INTRA ORAL — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAE-Chain — TP ORTHODONTICS INCHenry Schein — HENRY SCHEIN, INC.Creatures of the Sea — ORTHO TECHNOLOGY, INC.Elastic Chain — Ortho Organizers, Inc.Elastic Chain — Ortho Organizers, Inc.Elastic Chain — Ortho Organizers, Inc.CONLIN MOLAR BANDS — Ortho Arch Company IncPRO-ELAST — Ortho Pro Dent LLCOrtho Organizers — Ortho Organizers, Inc.Mini Power Sticks™ — Ortho Organizers, Inc.The Orthodontic Store — Young Innovations, Inc.Colored Chain — AMERICAN ORTHODONTICS CORPORATIONHenry Schein — HENRY SCHEIN, INC.HALO MOLAR BAND — Ortho Arch Company IncPhoenix Ultra Chain — PHOENIX ORTHODONTICS INCDESIGNERTIES® — G & H Wire Company, Inc.SAFE-T-TIES™ — Ortho Organizers, Inc.COLORS Power Chain — ORMCO CORPORATIONCONLIN MLAR BAND — Ortho Arch Company IncLEONE SPA — LEONE SPALEONE SPA — LEONE SPAPlak Smacker — Young Innovations, 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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