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DIBS Instructions for Use


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Federal law restricts this device to sale (or use) on the order of a licensed dental practitioner.


+ General Description

DIBS ® is a computer-guided system intended for use as an aid in orthodontic treatment planning and ultimately the virtual preparation of indirect bonding trays. The computer-generated trays are 3D-printed and are intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth.

+ Intended Use/Indications for Use

The Digital Indirect Bonding System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for orthodontic patient.

+ Intended Users

DIBS is for use by licensed dental practitioners.

+ Hardware Accessories

Hardware and Software Requirements for DIBS Software

Required

  • Computer
  • 64-bit PC (not compatible with Apple OS)
  • Windows 7 OS or newer
  • Minimum 8 MB Ram
  • Internet Capability
  • Graphics Card with minimum 4 MB Ram
  • Not yet intended for use with mobile devices

Security

It is strongly recommended that users protect against malicious software by installing an up-to-date, reputable antivirus protection and firewall product. Should wireless access be utilized, a strong WPA2 password is highly recommended. OrthoSelect takes no responsibility for malicious activity that may result from lack of current, appropriate IT security practices.

+ Clinical Accessories

Recommendations

  • Orthodontic Pumice:
    • Reliance Orthodontics
  • Etch:
    • Opal Etch by Ultradent
  • Primer:
    • Opal Seal by Ultradent (K090355)
    • Unitek-Transbond XT Primer by 3M Unitek
  • Adhesive:
    • Opal Bond Flow (Shade: A2) by Ultradent
    • Transbond Supreme LV by 3M Unitek
    • Flow Tain by Reliance Orthodontics
  • Curing Light:
  • Isolation:
    • Nola Dry Field System by Great Lakes Orthodontics

+ Optional Accessories

Utilizing the DIBS In-office service, users can print DIBS trays using an In-office 3D printer.

  • Compatible 3D Printers
    • VIDA by Envisiontec
    • VIDA 3 by Envisiontec
    • Micro by Envisiontec
    • Moonray by Sprintray

To achieve a properly configured, accurate and functional DIBS bonding tray, the correct 3D printing resin, which is compatible with the above-listed printers, must be used: E-IDB, ORTHO-IBT, produced by NextDent/Vertex Dental https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=459709&lpcd=EBHhttps://nextdent.com/wp-content/uploads/2016/02/UK_SDS-NextDent-Ortho-IBT-V01-2015.pdf

+ Intended Patient Population

DIBS is intended for the treatment of malocclusion.

+ Principles of Operation of the Device

  1. Use the DIBS software to digitally place brackets and create the indirect bonding tray.
  2. 3D Print the bonding tray
  3. Post-processing (cleaning and curing)
  4. Clinical use of the DIBS bonding tray

+ Conditions of Use

DIBS software is designed for use on computers in a dental office, lab, or clinical environment. DIBS trays are for use in a clinical environment.

Follow the instructions and precautions provided by your bracket manufacturer. For Isolation, use of a NOLA Dry Field System is strongly recommended. See clinical documentation: **__**

DIBS bond failures are rare. When they occur, the cause is typically saliva contamination of the bonding site or insufficient curing.

  1. To prevent contamination of the bonding site, it is highly recommended that a NOLA Dry Field System be used with DIBS.
  2. It is important to realize that the curing light intensity is reduced by almost half when curing bonding agent through a DIBS tray; so you should double the light intensity (turbo setting on some models) or the cure time.

ORTHOSELECT
831 E 340 S, SUITE 170
AMERICAN FORK, UT 84003
WWW.MYORTHOSELECT.COM
DIBS@MYORTHOSELECT.COM
TOLL FREE: 866-695-3319
DIRECT: 801-763-5039

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