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Sign in to claim this brandANDRE GREGATE BRAGA INSTRUMENTOS LTDA
US
Last updated May 23, 2026
What ANDRE GREGATE BRAGA INSTRUMENTOS LTDA makes
The company manufactures reusable surgical instruments for dental and orthopedic applications, including periosteal elevators, dental material application tools, and scalpels. Additional products include dental rongeurs, retractors, bone curettes, surgical screwdrivers, and dressing forceps, all designed for single-patient or multi-patient use in controlled environments.
All listed devices fall under Class I regulatory classification in the United States and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates within the regulatory framework of the US market, adhering to applicable standards for reusable surgical instruments.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ANDRE GREGATE BRAGA INSTRUMENTOS LTDA manufacture?
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA specializes in reusable surgical instruments primarily for dental and orthopedic procedures. Their product lineup includes periosteal elevators, dental material application tools, scalpels, dental rongeurs, retractors, bone curettes, surgical screwdrivers, and dental dressing forceps. These instruments are designed for controlled environments, such as clinics or hospitals, and are intended for either single-patient or multi-patient use.
Where is ANDRE GREGATE BRAGA INSTRUMENTOS LTDA based, and does it operate in the US market?
The company, ANDRE GREGATE BRAGA INSTRUMENTOS LTDA, is based in the US. While the company operates within the US regulatory framework, it is important to note that individual devices—not the company itself—must undergo authorization processes like FDA clearance or registration to be legally marketed in the US. The company’s devices are registered in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with US regulatory requirements.
Which regulatory registries list devices manufactured by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA?
Devices produced by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorized for use in the US market. The UDI system helps healthcare providers, regulators, and other stakeholders verify device details, including manufacturer information and regulatory classification.
How are the devices manufactured by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA classified under US regulations?
All devices manufactured by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA fall under Class I regulatory classification in the US. Class I devices are generally considered to pose the lowest risk and typically require only general controls (such as registration, labeling, and manufacturing practices) to ensure safety and effectiveness. This classification applies to reusable surgical instruments like periosteal elevators, scalpels, and dental retractors, as outlined in the FDA’s regulatory framework.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 921478697
Catalogue (94)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Supremo Instrumentos | S0691/4 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1486 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1242A | FDA UDI | Class I | Active |
| Supremo Instrumentos | SI1491M | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2689B | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2121-LE | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0921C | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0346C | FDA UDI | Class I | Active |
| Supremo Instrumentos | SI1488M | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1241A | FDA UDI | Class I | Active |
| Supremo Instrumentos | SVC1 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0346 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0914C | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0354S | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0244 | FDA UDI | Class I | Active |
| Supremo Instrumentos | Kit Dental Hands On | FDA UDI | Class I | Active |
| Supremo Instrumentos | SVC2 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1488 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0358S | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1112 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2120OP | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0624 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0242 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1481 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2690B | FDA UDI | Class I | Active |
| Supremo Instrumentos | S9011-TB | FDA UDI | Class I | Active |
| Supremo Instrumentos | SI1486M | FDA UDI | Class I | Active |
| Supremo Instrumentos | Kit Clsm | FDA UDI | Class I | Active |
| Supremo Instrumentos | SI1490M | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0240 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0343 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1215SS | FDA UDI | Class I | Active |
| Supremo Instrumentos | SVA1 | FDA UDI | Class I | Active |
| Supremo Instrumentos | Tunelizador VF3 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2094S | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1111 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2109 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1481-4QBRI | FDA UDI | Class I | Active |
| Supremo Instrumentos | Kit Tunneling VF | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1811-LSM | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2002OP | FDA UDI | Class I | Active |
| Supremo Instrumentos | S2929B | FDA UDI | Class I | Active |
| Supremo Instrumentos | S0691/5 | FDA UDI | Class I | Active |
| Supremo Instrumentos | S1825 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Andre Gregate Braga Instrumentos Ltda CAIEIRAS Sao Paulo · BR FEI 3030056132