FDA device listing

Rely-A-Bond

FDA device listing 1246969029 · RELIANCE ORTHODONTIC PRODUCTS, INC.

Key facts

Proprietary names Rely-A-Bond
Owner/operator RELIANCE ORTHODONTIC PRODUCTS, INC.
Owner/operator number 1420089
Premarket submissions K895521
Product codes DYH
Device names DYH - Adhesive, Bracket And Tooth Conditioner, Resin
Device class Class II
Classification regulations (21 CFR) 872.3750
Review panels Dental
Registered establishments RELIANCE ORTHODONTIC PRODUCTS, INC.
Establishment registrations 1420089
FEI numbers 1420089
Establishment operations Repackager/Relabeler, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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