ANMAT Issues Warning About Counterfeit WORLD CLASS TECHNOLOGY Brackets in Argentina
Date: June 12, 2025
The National Administration of Medicines, Food, and Medical Technology (ANMAT) of Argentina has issued an important alert concerning the discovery of counterfeit orthodontic brackets marketed under the brand WORLD CLASS TECHNOLOGY.
Discovery of Counterfeit Products
During routine inspections, the Market Control Department identified fake units of WORLD CLASS TECHNOLOGY USA brackets being sold at a medical product vendor located in Resistencia, Chaco Province. These brackets are classified as a Class II medical device and are intended for use in orthodontic treatments.
Legitimate Manufacturer and Product Registration
The legitimate owner of the WORLD CLASS TECHNOLOGY brand in Argentina is RB Orthodontic, represented by Bruno Ricardo Miguel. The company holds the official product registration number PM N° 1781-2 for "Orthodontic Systems," which includes brackets under the WORLD CLASS TECHNOLOGY CORPORATION name.
ANMAT clarified that the suspicious brackets found, specifically labeled as:
- Brackets H- World Class Technology USA – 916.2152 – H4.022 U HKS 345 – 7×7 CA – Lot# MO098954
are counterfeit. The lot number MO098954 has not been imported or distributed by RB Orthodontic or any authorized entity in Argentina. Consequently, there are no legitimate brackets with this lot number available in the local market.
Identifying Genuine vs. Counterfeit Brackets
One of the key distinguishing features pointed out by ANMAT is the base or mesh of the bracket that adheres to the tooth. Genuine WORLD CLASS TECHNOLOGY brackets have a dotted pattern on their base, whereas the counterfeit versions show a grooved or grooved (acanalada) pattern.
Recommendations from ANMAT
For Patients:
- Seek orthodontic and dental treatments only from establishments authorized by health authorities.
- Ensure that the health professional supervising the treatment is qualified and responsible.
- Check the identification and registration details of the orthodontic products being used. Officially approved products in Argentina must clearly display the brand name, manufacturer, importer, responsible party’s address in Argentina, and the ANMAT registration number (e.g., PM XXXX-XX).
For Healthcare Professionals:
- Purchase only medical products that have valid registration and proper identification.
- Maintain thorough documentation of the origin of the products and retain user manuals for reference.
ANMAT continues to monitor the medical device market to protect patient safety and uphold product quality standards.
For further information or to report suspicious medical products, individuals and professionals can contact ANMAT through official channels.
This alert is part of ANMAT’s ongoing commitment to safeguard public health by ensuring the authenticity of medical devices in Argentina.
