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    Dentsply Sirona Orthodontics Inc.

    Manufacturer
    🇺🇸 United States·3 Importers

    DENTSPLY SIRONA INC

    FDA registration
    DENTSPLY SIRONA INC·35 products·🇺🇸 United States

    Dentsply Sirona Orthodontics Inc.

    FDA registration
    Dentsply Sirona Orthodontics Inc.·19 products·🇺🇸 United States

    Dentsply Sirona Orthodontics Inc.

    FDA registration
    Dentsply Sirona Orthodontics Inc.·7 products·🇺🇸 United States

    SURESMILE ALIGNER

    FDA Adverse Event
    Injury ·ORAMETRIX INC.·Product code NXC·January 31, 2019

    OSSEOSPEED EV 4.2 S - 11 MM

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·March 31, 2025

    OSSEOSPEED EV 4.2 S - 11 MM

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·March 31, 2025

    BYTE ALIGNERS

    FDA Adverse Event
    Injury ·DENTSPLY SIRONA INC·Product code NXC·April 30, 2026

    DENTAL BURR

    FDA Adverse Event
    Malfunction ·DENTSPLY SIRONA INC·Product code DZC·April 30, 2025

    DENTSPLY SIRONA DENTAL ELECTRIC HANDPIECE

    FDA Adverse Event
    Injury ·DENTSPLY SIRONA INC.·Product code EFB·February 18, 2026

    ALIGNER

    FDA Adverse Event
    Injury ·DENTSPLY SIRONA INC.·Product code NXC·January 22, 2026

    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

    FDA Recall
    Open, Classified ·Dentsply IH, Inc.·Product code NDP·July 24, 2025

    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

    FDA Recall
    Open, Classified ·Dentsply IH, Inc.·Product code NDP·July 24, 2025

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110131911·MYSTIQUE® MB Roncone 018/UR3 8A 2M HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807189112601·IN-OVATION® R RNC 022/UR1 18T 5A

    IN-OVATION ® X

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807289331101·In-Ovation ® X Base Rx 018/LR3 -11T 7A2MHK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807100121081·IN-OVATION® C CCO 018/UR2 LT 3T 9A

    MICROARCH®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D80772312111·MicroArch® Base Rx 022/LR1 -1T0A0OF HK

    LOWLAND

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D8070362265T1·LOWLAND NITI EURO 16X22 UP PK10

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100232611·IN-OVATION® C Roncone 022/UL3 0T 8A 2M HK