FDA device listing

Dental LT Clear; E-Guard; NextDent Ortho Clear; NextDent Ortho Clear E-Guard; NextDent Ortho Rigid

FDA device listing 1687387403 · Imagine Milling Technologies, LLC

Key facts

Proprietary names Dental LT Clear; E-Guard; NextDent Ortho Clear; NextDent Ortho Clear E-Guard; NextDent Ortho Rigid
Owner/operator Imagine Milling Technologies, LLC
Owner/operator number 10044468
Product codes DYT
Device names DYT - Maintainer, Space Preformed, Orthodontic
Device class Class I
Classification regulations (21 CFR) 872.5525
Review panels Dental
Registered establishments IMAGINE MILLING TECHNOLOGIES, LLC
Establishment registrations 3009727738
FEI numbers 3009727738
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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