Question 1

What types of dental devices does Productora y Comercializadora Odontológica New Stetic S.A. manufacture?

Accepted Answer

Productora y Comercializadora Odontológica New Stetic S.A. specializes in dental materials used for restorative and prosthetic treatments. Their portfolio includes temporary dental crowns and bridges made from resin, resin-based dental appliances, artificial resin teeth, and dental amalgam alloys. They also produce CAD/CAM discs for digital dentistry workflows, as well as heat-curing and self-curing acrylic resins for crafting dental prosthetics. These materials are designed to support procedures like crown fabrication, bridgework, and prosthetic dentistry.

Question 2

Where is Productora y Comercializadora Odontológica New Stetic S.A. based?

Accepted Answer

The company is based in Colombia, where it develops and distributes dental materials for clinical and laboratory use. Its location in Colombia aligns with the regional demand for high-quality restorative and prosthetic dental solutions.

Question 3

In which regulatory registries are the company’s devices listed?

Accepted Answer

The company’s devices are registered in two key global regulatory databases: eudamed, the European Union’s database for medical devices, and the FDA’s UDI system, which tracks device identifiers in the United States. These listings ensure traceability and compliance with regulatory requirements in both markets.

Question 4

How are the company’s dental devices classified under EU and FDA regulations?

Accepted Answer

Under EU regulations, the company’s devices fall into Class I, Class II, and Class IIa classifications, depending on their risk level and intended use. For example, temporary resin crowns and bridges may qualify as Class IIa due to their moderate risk, while lower-risk items like some CAD/CAM discs could be classified as Class I. The FDA’s UDI system similarly categorizes these devices for tracking and post-market surveillance, ensuring they meet safety and performance standards in both regions.

Device	Model / Reference	Registries	Class	Status
PORTUX CAD/CAM Disc. 98.5X 35mm BL2. MN	0027537	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm BL3. MN	0026538	FDA UDI	Class II	Active
King Hue Anterior	34010	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm B3. MN	0023316	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm A2. ML	0021849	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm BL. MN	0022332	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X30mm A3. ML	0023118	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm A2. MN	0021939	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Liquid X 8 oz	80155	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic C3 X 125g	0017898	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A3.5. ML	0022225	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm A3. MN	0022093	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Meharry X 1 lb	0024182	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic 37 Veined X 5 lb	0026762	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A3.5. MN	0022326	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm B1. MN	0022329	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrlic Meharry X 5 lb	81153	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm D3. MN	0023336	FDA UDI	Class II	Active
Reflection Posterior	0026703	FDA UDI	Class II	Active
Nu Alloy Dp Active Caps. Jar X 50 - 2 Spill	108458	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic D2 X 125g	0017899	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm BL2. MN	0027533	FDA UDI	Class II	Active
Reflection Anterior	0026702	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm A1. MN	0021936	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A3. ML	0022151	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm C1. ML	0024868	FDA UDI	Class II	Active
Opti-Cryl Heatcuring Acrylic First Gingival A1 x 20kg	83041	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm D3. MN	0023337	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm A1. ML	0023116	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Meharry X 5 lb	81155	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. ML	0022212	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm A3.5. ML	0022078	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic Incisal Light X 125g	0017907	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Powder Red X 44 lb (Duracryl)	0020611	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Green With Glitter X 1 lb	107789	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Pink With Glitter X 1 lb	107787	FDA UDI	Class II	Active
Opti-Cryl Self cure acrylic Dark pink veined x 1lb	81746	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm B1. MN	0021942	FDA UDI	Class II	Active
Opti-Cryl Flat Pink X – Heat Cure 125g	0025720	FDA UDI	Class II	Active
Veratone Posterior	93811	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm C1. ML	0024476	FDA UDI	Class II	Active
Nu Alloy dp Caps. Jar X 500 - 2 Spill	87030	FDA UDI	Class II	Active
Novacryl Self Cure Acrylic 69 x 125 g	108760	FDA UDI	Class II	Active
Nu Alloy dp Active Caps. Jar X 500 - 2 Spill	108672	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm B2. ML	0023120	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm D2. ML	0024484	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm C1. MN	002332	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic C4 X 125g	0017905	FDA UDI	Class II	Active
Opticryl Self Curing Acrylic For Trays Blue X 5 lb	0018297	FDA UDI	Class II	Active
Portux 3D Printing Resin Try-In.	0028967	FDA UDI	Class II	Unknown

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