Question 1

What dental devices does Odne AG manufacture?

Accepted Answer

Odne AG manufactures dental devices including injection cannulas, polymerization lamps, composite resins, delivery system instruments, and irrigation needles. Their specific products consist of tips, cure devices, and cleaning instruments designed for dental procedures.

Question 2

Where is Odne AG based?

Accepted Answer

Odne AG is based in the United States, as indicated in the company's device data.

Question 3

Which regulatory registries list Odne AG's devices?

Accepted Answer

Odne AG's devices are listed in the FDA 510(k) and FDA UDI registries, which are regulatory databases for medical devices in the United States.

Question 4

How are Odne AG's devices classified?

Accepted Answer

Odne AG's devices are classified as Class I and Class II, which are regulatory categories indicating the level of control needed to ensure their safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
OdneFill Tips 25mm	E-8020	FDA UDI	Class I	Active
OdneCure	E-0001	FDA UDI	Class II	Active
OdneFill Tip	E-8000	FDA UDI	Class I	Active
OdneClean	E-0003	FDA UDI	Class II	Active
OdneClean Tip	E-0005	FDA UDI	Class II	Active
OdneFill	E-0002	FDA UDI	Class II	Active
OdneCure Tip	E-0008	FDA UDI	Class II	Active
OdneClean	K233844	FDA 510(k)	Class II	Active

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