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 18mm D2. ML	0024482	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic for characterization. 8 jar x 40g	0021953	FDA UDI	Class II	Active
PORTUX 3D Printing Resin Try-In BL4	0028045	FDA UDI	Class II	Unknown
Novacryl Self Curing Acrylic A3.5 X 125g	0017892	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic A4 X 125g	0017893	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic B1 X 125g	0017904	FDA UDI	Class II	Active
Portux 3D Printing Resin Cast	0028439	FDA UDI	Class I	Unknown
T-Real Posterior	66011	FDA UDI	Class II	Active
Nu Alloy Caps. Jar X 500 - 1 Spill	87020	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN	0023326	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm BL2. MN	0027536	FDA UDI	Class II	Active
Duratone-n Posterior vita shades	69020	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm BL. ML	0021867	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Light Pink Veined X 22 lb	81193	FDA UDI	Class II	Active
Nu Alloy Caps. Jar X 50 - 1 Spill	86930	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm BL2. MN	0027534	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Clear X 5 lb	81157	FDA UDI	Class II	Active
Nu Alloy Active Caps. Jar X 50 - 1 Spill	86955	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm C2. ML	0024481	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm BL2. MN	0027535	FDA UDI	Class II	Active
Opti-Cryl High Impact Acrylic Original x 5 lb	83268	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Liquid X 32 oz	80021	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A3. MN	0022323	FDA UDI	Class II	Active
Portux 3D Printing Resin Try-In	0028966	FDA UDI	Class II	Unknown
Opti-Cryl Self Curing Acrylic Meharry X 22 lb	0019888	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm D2. ML	0024483	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm B2. MN	0022381	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Trays Blue X 1 lb	0015822	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm A2. ML	0021861	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Meharry X 22 lb	81196	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic C1 X 125g	0017897	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic B3 X 125g	0017895	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Light Pink X 22 lb	81199	FDA UDI	Class II	Active
Opti-Cryl Self cure acrylic Meharry x 1lb	81154	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Original X 22 lb	83238	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm A3. ML	0022083	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X30mm C1. MN	0024938	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN	0023317	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic Liquid X 8 oz	0025707	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X30mm. Original Dental Base	0022160	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm B2. ML	0022360	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Dark Pink X 1 lb	82970	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm A1. ML	0021858	FDA UDI	Class II	Active
Opti-Cryl Smooth Original – Heat Cure 125g	0025716	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm D3. ML	0026358	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Pink X 1 lb	0023970	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm C2. MN	0023325	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic 37 Veined X 1 lb	0026763	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm BL. ML	0021855	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic A3 X 125g	0017903	FDA UDI	Class II	Active

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