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
Novacryl Self Curing Acrylic D3 X 125g	0017901	FDA UDI	Class II	Active
Deleey Centerline Posterior With Linear Metal	23007	FDA UDI	Class II	Active
Portux 3D Printing Resin Dental Models	0020075	FDA UDI	Class I	Unknown
PORTUX CAD/CAM Disc. 98.5X25mm D3. MN	0023338	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X18mm D2. MN	0023333	FDA UDI	Class II	Active
Splendid Anterior	54010	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm A1. MN	0022317	FDA UDI	Class II	Active
Nu Alloy dp40 Caps. Jar X 500 - 1 Spill	0013416	FDA UDI	Class II	Active
Opti-Cryl Smooth C – Heat Cure 125g	0025718	FDA UDI	Class II	Active
Nu Alloy Dp Active Caps. Jar X 50 - 3 Spill	108457	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 35mm BL3. MN	0026540	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm D2. ML	0024872	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm B2. MN	0024140	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade Clear With Glitter X 1 lb	107788	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm C2. ML	0024480	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN	0022230	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Pink Veined 37 X 22 lb	0027334	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm A3. ML	0022078	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Original X 5 lb	83255	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 35mm A1. MN	0024142	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Liquid X 8 oz	0023196	FDA UDI	Class II	Active
Tiziano Posterior	68002	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X20mm BL. MN	0021933	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm B1. ML	0022154	FDA UDI	Class II	Active
Deleey Centerline Posterior With Linear Metal	23005	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 20mm C1. ML	0024477	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Original X 1 lb	0022600	FDA UDI	Class II	Active
Royal Anterior	52010	FDA UDI	Class II	Active
Opti-Cryl Self cure acrylic light pink veined x 1lb	81757	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm D2. MN	0024940	FDA UDI	Class II	Active
Ultradent Anterior	0011537	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Light Pink X 5 lb	82491	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 25mm C1. ML	0024478	FDA UDI	Class II	Active
O-Cryl Self Curing Acrylic Shade White X 1 lb	0020103	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic 37 Veined X 1 lb	0026767	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 30mm BL. MN	0024141	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Light Pink X 5 lb	81151	FDA UDI	Class II	Active
King Hue Posterior	34010	FDA UDI	Class II	Active
Novacryl Self Curing Acrylic A0 X 125g	0017902	FDA UDI	Class II	Active
Opti-Cryl Heat Curing Acrylic Light Pink X 1 lb	82990	FDA UDI	Class II	Active
Opti-Cryl Self Curing Acrylic Clear X 22 lb	81200	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 18mm A1. ML	0021846	FDA UDI	Class II	Active
PORTUX CAD/CAM Disc. 98.5X 35mm A1. ML	0022576	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Liquid X 32 oz	81198	FDA UDI	Class II	Active
Opti-Cryl Pour Acrylic Pink Veined 37 X 5 lb	0027335	FDA UDI	Class II	Active
Entacryl ®	0012726 CE	EUDAMED	Class IIa	Active
Veracril	0017168 CE	EUDAMED	Class IIa	Active
Veracril	83780 CE	EUDAMED	Class IIa	Active
Novacryl	82237 CE	EUDAMED	Class IIa	Active
Olympic® Plus	110850 CE	EUDAMED	Class IIa	Active

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