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 30mm B1. MN	0024139	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Orange X 1 lb	111191	FDA UDI	Class II	Active
Nu Alloy dp Active Caps. Jar X 500 - 1 Spill	86958	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Clear X 1 lb	83760	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic C2 X 125g	0017900	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Liquid X 8 oz	108745	FDA UDI	Class II	Active
Portux 3D Printing Resing Try-In BL4	0028444	FDA UDI	Class II	Unknown
PORTUX CAD/CAM Disc. 98.5X18mm BL. MN	0021945	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm BL. ML	0023121	FDA UDI	Class II	Active
Opti-Cryl Smooth B – Heat Cure 125g	0025714	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm C2. ML	0024479	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic Incisal Dark X 125g	0017908	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic B2 X 125g	0017894	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A2. ML	0022148	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic A2 X 125g	0017891	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm C2. ML	0024870	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm B2. ML	0022350	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Clear X 22 lb	81199	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A2. MN	0022320	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Original X 22 lb	83250	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Yellow With Glitter X 1 lb	107784	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm C2. MN	0023324	FDA UDI	Class II	Active
Royal Posterior	52011	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Clear X 5 lb	81156	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Original X 5 lb	0022602	FDA UDI	Class II	Active
T-Real Anterior	66010	FDA UDI	Class II	Active
Ultradent Posterior	0011538	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Pink Veined 37X 1 lb	0027336	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN	0022235	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Original X 22 lb	0022605	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X20mm A3. MN	0022088	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm B3. MN	0023315	FDA UDI	Class II	Active
Opti-Cryl Smooth VR5 – Heat Cure 125g	0025712	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic 37 Veined X 5 lb	0026764	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X20mm A1. MN	0021924	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A1. ML	0022145	FDA UDI	Class II	Active
Baby Dent Anteriors	26011	FDA UDI	Class II	Active
Tiziano Anterior	68001	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic B4 X 125g	0017896	FDA UDI	Class II	Active
Opti-Cryl Self cure Acrylic Clear x 1lb	110735	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm C2. MN	0024939	FDA UDI	Class II	Active
PORTUX 3D Printing Resin Try-In A1	0028960	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic B0 X 125g	0017906	FDA UDI	Class II	Active
Opti-Cryl High Impact Acrylic Original X 22 lb	83257	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm A2. MN	0024137	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X25mm D2. MN	0023335	FDA UDI	Class II	Active
Opti-Cryl Self Cure liquid Acrylic x 8 oz	80020	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 35mm A2. ML	0024457	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm D2. MN	0023334	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm A1. MN	0024136	FDA UDI	Class II	Active

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