Question 1

What types of medical devices does Denplus Inc manufacture?

Accepted Answer

Denplus Inc specializes in dental materials used primarily in orthodontic and restorative procedures. Their product line includes resin-based fabrication materials for dental appliances, impression tray materials for capturing oral impressions, dental base plates for bite registration, and specialized waxes like bite registration rim wax. These materials are designed for use in dental laboratories and clinical settings.

Question 2

Where is Denplus Inc based, and what is its primary focus?

Accepted Answer

Denplus Inc is based in the United States. The company focuses on developing dental materials that support orthodontic and restorative treatments, such as appliances, impression trays, and bite registration aids. Their products are tailored for dental professionals working in laboratories or clinical environments.

Question 3

Which regulatory registries list Denplus Inc’s devices?

Accepted Answer

Denplus Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. Additionally, several of their products have been authorised through the FDA’s 510(k) premarket notification process, which is a pathway for demonstrating substantial equivalence to a legally marketed predicate device.

Question 4

How are Denplus Inc’s devices classified under FDA regulations?

Accepted Answer

Denplus Inc’s devices are classified under two categories by the FDA: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific use and potential risk associated with each product.

Question 5

What is the intended use of Denplus Inc’s dental materials?

Accepted Answer

Denplus Inc’s dental materials are intended for use in dental laboratories and clinical settings to support procedures like orthodontic appliance fabrication, capturing oral impressions, and bite registration. These materials are designed to aid dental professionals in creating custom-fit devices, repairing existing appliances, and ensuring accurate impressions for restorative treatments.

Device	Model / Reference	Registries	Class	Status
Dp-Repair	1061116	FDA UDI	Class II	Active
High-Wave	1142100	FDA UDI	Class II	Active
Impact-20	1031105	FDA UDI	Class II	Active
DP-Tray-F	1122100	FDA UDI	Class I	Active
High-Wave	1141207	FDA UDI	Class II	Active
Dp-Repair	1071309	FDA UDI	Class II	Active
Pour-Plus	1151316	FDA UDI	Class II	Active
Pour-Plus	1151102	FDA UDI	Class II	Active
Dp-Repair	1061204	FDA UDI	Class II	Active
BasePlate Wax	3001101	FDA UDI	Class I	Active
Impact-20	1031305	FDA UDI	Class II	Active
Dp-Repair	1061316	FDA UDI	Class II	Active
Dp-Repair	1061302	FDA UDI	Class II	Active
Dp-Repair	1071116	FDA UDI	Class II	Active
Dp-Repair	1071105	FDA UDI	Class II	Active
Laminated Bite Wafers-Wax	3003102	FDA UDI	Class I	Active
Dp-Repair	1061303	FDA UDI	Class II	Active
Pour-Plus	1151202	FDA UDI	Class II	Active
Dp-Repair	1061103	FDA UDI	Class II	Active
Impact-20	1031201	FDA UDI	Class II	Active
High-Wave	1141116	FDA UDI	Class II	Active
Dp-Repair	1062100	FDA UDI	Class II	Active
Dp-Repair	1061203	FDA UDI	Class II	Active
Dp-Repair	1071103	FDA UDI	Class II	Active
Premium Tray	1121114	FDA UDI	Class I	Active
High-Wave	1141302	FDA UDI	Class II	Active
High-Wave	1141217	FDA UDI	Class II	Active
High-Wave	1142200	FDA UDI	Class II	Active
Bite Occlusion Rims - Wax	3003101	FDA UDI	Class I	Active
High-Wave	1141309	FDA UDI	Class II	Active
Impact-Plus, Impact-20, Dp97, Dp97-20, Dp-Pour And Dp-Repair	K991996	FDA 510(k)	Class II	Active
Hi-Wave; Pour-Plus	K011762	FDA 510(k)	Class II	Active

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