Question 1

What types of medical devices does Zendo Direct AG manufacture?

Accepted Answer

Zendo Direct AG specializes in dental materials primarily used in restorative and endodontic treatments. Their portfolio includes silicone-based dental impression materials for creating molds of teeth, dental composite resins for repairing and restoring tooth structure, and calcium hydroxide dental cements for protecting dental pulp. They also produce endodontic filling materials for root canal treatments, dentine bonding agents to adhere to tooth surfaces, and temporary dental crowns or bridges for interim restorations.

Question 2

Where is Zendo Direct AG based, and where are their devices authorised for use?

Accepted Answer

Zendo Direct AG is based in the United States. Their devices are authorised for commercial distribution in the US, where they comply with applicable regulatory requirements for dental materials.

Question 3

Which regulatory registries list Zendo Direct AG’s devices?

Accepted Answer

Zendo Direct AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for dental materials classified under FDA regulations.

Question 4

How are Zendo Direct AG’s devices classified by regulatory authorities?

Accepted Answer

All of Zendo Direct AG’s listed devices fall under FDA Class II regulation. This classification applies to dental materials that pose moderate risk and require special controls to ensure their safety and effectiveness, such as silicone impression materials, composite resins, and endodontic fillings.

Device	Model / Reference	Registries	Class	Status
MTA-Flow Fast Set	ZEN-MTA-FLOFST	FDA UDI	Class II	Active
Select Supratemp	TCB-ST-A3	FDA UDI	Class II	Active
Select Transbite	SELSIL-TRANS-B	FDA UDI	Class II	Active
Select Sil Light Body	SEL-SIL-LB-SHFS-50	FDA UDI	Class II	Active
MTA Firm-Fast Set	ZEN-MTA-FRMFSTSET	FDA UDI	Class II	Active
Select NanoFill	FIL-RS-A2	FDA UDI	Class II	Active
Select Flow	SEL-LCFLOWA2	FDA UDI	Class II	Active
Select Sil Heavy Viscosity	SEL-SIL-SHFS-GR50	FDA UDI	Class II	Active
Select NanoFill	FIL-RS-A1	FDA UDI	Class II	Active
Select NanoFill	FIL-RS-A3	FDA UDI	Class II	Active
MTA Capsules	ZEN-MTA-UNI	FDA UDI	Class II	Active
Select Sil Heavy Viscosity	SEL-SIL-SHRS-GR50	FDA UDI	Class II	Active
Select Rigid BR	RIGBR-LB-SH	FDA UDI	Class II	Active
Select SE-Bond LC	SEL-ETCH-LC-5ml	FDA UDI	Class II	Active
Select Flow	SEL-LCFLOWA1	FDA UDI	Class II	Active
Select Sil Medium Body	SEL-SIL-MB-SHFS-PNK5	FDA UDI	Class II	Active
Select Sil Medium Body	SEL-SIL-MB-SHRS-PNK5	FDA UDI	Class II	Active
Select Calcium Hydroxide Liner LC	CAL-LINER	FDA UDI	Class II	Active
MTA Firm- Normal Set	ZEN-MTA-FRMNSET	FDA UDI	Class II	Active
Select NanoFill	FIL-RC-A1	FDA UDI	Class II	Active
Select Sil Light Body	SEL-SIL-LB-SHRS-50	FDA UDI	Class II	Active
Select NanoFill	FIL-RC-A2	FDA UDI	Class II	Active
Select Flow	SEL-LCFLOWA3	FDA UDI	Class II	Active
Select Sil Firm Putty	SEL-SIL-FR-B400	FDA UDI	Class II	Active

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