FDA device listing

Cementing Wedge,DME Wedge,Power Ring,QuickConnect Anatomy Band,QuickConnect Carrier,R Matrix,Separator Wedge,Sure…

FDA device listing 1222669849 · RHONDIUM LIMITED

Key facts

Proprietary names Cementing Wedge,DME Wedge,Power Ring,QuickConnect Anatomy Band,QuickConnect Carrier,R Matrix,Separator Wedge,Sure Band,SureMatrix
Owner/operator RHONDIUM LIMITED
Owner/operator number 10049515
Product codes DZN
Device names DZN - Instruments, Dental Hand
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments RHONDIUM LIMITED
Establishment registrations 3011789026
FEI numbers 3011789026
Establishment operations Manufacturer
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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