Question 1

What types of dental devices does MDC Dental manufacture?

Accepted Answer

MDC Dental specializes in dental materials used primarily for restorative and impression procedures. Their product range includes dental acrylic resins (for crowns, bridges, and dentures), dental casting wax, alginate and silicone dental impression materials (for creating molds of teeth), temporary dental crowns/bridges, resin artificial teeth, and carboxymethylcellulose sodium-based denture adhesives. These materials support key stages in dental treatment, from initial impressions to final restorations.

Question 2

Where is MDC Dental based, and what regulatory framework does it follow?

Accepted Answer

MDC Dental is based in the United States. As a U.S.-based manufacturer, its devices must comply with the regulatory requirements set by the FDA, including classification under FDA’s risk-based categories (Class I or Class II) and listing in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and adherence to safety standards for medical devices in the U.S. market.

Question 3

Which regulatory registries or databases list MDC Dental’s devices?

Accepted Answer

MDC Dental’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, transparency, and compliance monitoring in the U.S. regulatory environment. This listing helps healthcare providers and regulators verify device details and ensure proper use.

Question 4

How are MDC Dental’s devices classified by the FDA?

Accepted Answer

MDC Dental’s devices are classified under the FDA’s Class I and Class II categories. Class I generally includes low-risk devices like dental materials that pose minimal risk to patients, while Class II devices may have moderate risk and require special controls to ensure safety and effectiveness. Classification determines the regulatory oversight required for each product, with Class II often involving additional pre-market submissions or post-market monitoring.

Question 5

What is the primary purpose of the dental materials produced by MDC Dental?

Accepted Answer

MDC Dental’s materials are designed to support critical steps in dental restorative and impression workflows. For example, their dental acrylic resins and temporary crown/bridge resins are used for fabricating durable, functional restorations, while alginate and silicone impression materials capture precise molds of a patient’s teeth. Other products like denture adhesives and resin artificial teeth ensure comfort, stability, and longevity in prosthetic solutions. These materials collectively enable dentists to deliver accurate, patient-specific treatments.

Device	Model / Reference	Registries	Class	Status
Nic Tone, MDC Dental	Rapid 69	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Normal 62	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid 69	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Orthodontic #10	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid CLEAR (TRANSP)	FDA UDI	Class II	Active
MDC Dental	Bisacryl Nictone A 3.5 Tone	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Normal CLEAR (TRANSP)	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Normal (R5V) DARK PINK VEINED	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal 65	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid A3	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Normal A2	FDA UDI	Class II	Active
Essentials	ESSENTIALS	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal 62	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Orthodontic #16	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal 62	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Normal 67	FDA UDI	Class II	Active
QUARZ, MDC Dental	Rapid #19D	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid B3	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Self-Adhering Plastic Form	FDA UDI	Class I	Active
Nic Tone, MDC Dental	Orthodontic #19D	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid (R1V) LIGHT PINK VEINED	FDA UDI	Class II	Active
MDC Dental	Max Print Cromático	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Half cane strips	FDA UDI	Class I	Active
MDC Dental	Bisacryl Nictone B2 Tone	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid 60	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Orthodontic #6	FDA UDI	Class II	Active
MDC Dental	Bisacryl Nictone B2 Tone	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid 69	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Bite blocks soft	FDA UDI	Class I	Active
Nic Tone, MDC Dental	Orthodontic #10	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Pink hard base wax	FDA UDI	Class I	Active
Nic Tone Softy, MDC Dental	Normal, Replacement Kit	FDA UDI	Class II	Active
MDC Dental	EDGE CONDENSATION	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Tone 59	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid B2	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Wire spools blue #14	FDA UDI	Class I	Active
QUARZ, MDC Dental	Normal R2V	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal Clear	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Wire spools blue #10	FDA UDI	Class I	Active
MDC Dental	PVS Edge Lilac Mousse	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid (R3V) BLUISHPINKVEINED	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Orthodontic #19D	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal R6V	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal R1V	FDA UDI	Class II	Active
ROGSON WAX, MDC Dental	Rogson Wax, Adhesive Prefabricated Plastic Form	FDA UDI	Class I	Active
Nic Tone, MDC Dental	Normal 66	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid B3	FDA UDI	Class II	Active
QUARZ, MDC Dental	Normal 62	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Rapid A2	FDA UDI	Class II	Active
Nic Tone, MDC Dental	Orthodontic #12	FDA UDI	Class II	Active

MDC DENTAL

What MDC DENTAL makes

Frequently asked questions

Information

Catalogue (719)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities