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 3D Printing Resin Model 2.0	0029134	FDA UDI	Class I	Unknown
O-Cryl Self Curing Acrylic Shade Clear X 1 lb	0023194	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Powder Pink X 22 lb (Duracryl)	0020500	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm B1. ML	0021864	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic A1 X 125g	0017890	FDA UDI	Class II	Active
Opti-Cryl Self cure acrylic Original x 1lb	83269	FDA UDI	Class II	Active
Duratone-n Ant vita shades	69018	FDA UDI	Class II	Active
Opti-Cryl Beige A4 – Heat Cure 125g	0025722	FDA UDI	Class II	Active
Splendid Posterior	54011	FDA UDI	Class II	Active
Nu Alloy Caps. Jar X 50 - 2 Spill	86910	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Original X 5 lb	83271	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm BL3. MN	0026536	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Liquid Shade Yellow X 8oz	0017917	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm B1. ML	0023119	FDA UDI	Class II	Active
Opti-Cryl High Impact Acrylic Original x 1 lb	108694	FDA UDI	Class II	Active
Portux 3D Printing Resin Try-In	0026110	FDA UDI	Class II	Unknown
PORTUX CAD/CAM Disc. 98.5X 30mm BL3. MN	0026539	FDA UDI	Class II	Active
Duratone-n Posterior	69011	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm C1. MN	0023321	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Liquid X 32 oz	80156	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X30mm. Meharry Dental Base	0026110	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Liquid Shade Pink X 8oz	0017919	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Meharry X 1 lb	81152	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 35mm A2. MN	0024145	FDA UDI	Class II	Active
Veratone Anterior	93810	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm A3. MN	0024138	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm B1. ML	0021852	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Liquid Shade Blue X 8oz	0017918	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Original X 1 lb	83272	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X20mm A2. MN	0021927	FDA UDI	Class II	Active
Opti-Cryl Red V51-Heat Cure 125g	0025708	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 35mm A2. MN	0024143	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Blue X 1 lb	111193	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm BL3. MN	0026537	FDA UDI	Class II	Active
Opti-Cryl Smooth Meharry – Heat Cure 125g	0025710	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm C1. MN	0023323	FDA UDI	Class II	Active
Duracryl Flow Self Cure Acrylic For Inlay Pattern Resin Kit 60g+55cc	0011188	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrlic Meharry X 1 lb	81154	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Clear X 5 lb	0024452	FDA UDI	Class II	Active
Portux 3D Printing Resin SG x 1000g	0027364	FDA UDI	Class I	Unknown
Portux 3D Printing Resin Cast	0027366	FDA UDI	Class I	Unknown
Duratone-n Anterior	69010	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm A2. ML	0023117	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Meharry X 5 lb	0024183	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm BL. ML	0022157	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm B2. MN	0022376	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm B2. ML	0022355	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm A3.5. ML	0024671	FDA UDI	Class II	Active
Portux 3D Printing Resin Basic Gray x 500g	0029132	FDA UDI	Class I	Unknown
O-Cryl Self Curing Acrylic Shade Fuchsia With Glitter X 1 lb	107785	FDA UDI	Class II	Active

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