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Sign in to claim this brandAMERICAN MEDICAL & DENTAL SUPPLIES INC
US
Last updated May 25, 2026
What AMERICAN MEDICAL & DENTAL SUPPLIES INC makes
The company manufactures single-use examination and treatment gloves in nitrile, hevea-latex, and polychloroprene materials, all non-powdered and non-antimicrobial, as well as sterilization packaging for medical and dental procedures. Their product line includes branded glove lines such as Aura 300, Aura Touch, Aura Lotus, and Aura Elite, alongside dental supply kits under the DDS Dental Supplies brand.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for medical and dental supplies.
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 American Medical & Dental Supplies Inc manufacture?
American Medical & Dental Supplies Inc specializes in single-use medical and dental examination and treatment gloves, as well as sterilization packaging. Their gloves come in three materials: nitrile, hevea-latex, and polychloroprene, and are all non-powdered and non-antimicrobial. The company also produces branded glove lines like Aura 300, Aura Touch, Aura Lotus, and Aura Elite, alongside dental supply kits under the DDS Dental Supplies brand.
Where is American Medical & Dental Supplies Inc based?
The company is based in the United States, where it operates and manufactures its medical and dental supplies. This location ensures compliance with applicable U.S. regulatory standards for these types of devices.
Which regulatory registries list devices manufactured by American Medical & Dental Supplies Inc?
Devices from American Medical & Dental Supplies Inc are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability.
How are the devices manufactured by American Medical & Dental Supplies Inc classified by the FDA?
The company’s devices fall under two FDA classification categories: Class I and Class II. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification depends on the specific device type and its intended use.
Why are some of the company’s gloves classified as Class II while others are Class I?
The FDA assigns device classifications based on risk levels and regulatory history. For example, gloves made from materials like nitrile or polychloroprene may be classified as Class II if they require additional controls to ensure safety and effectiveness, such as specific testing for durability or barrier protection. In contrast, certain latex gloves or simpler packaging may qualify as Class I due to lower inherent risks and reliance on general manufacturing controls.
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
- 018638145
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aura 300 | DDS-401 | FDA UDI | Class I | Active |
| Aura Touch | DDS-103 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCM3DDS | FDA UDI | Class II | Active |
| Aura Lotus | DDS-804 | FDA UDI | Class I | Active |
| Aura Elite | DDS-501 | FDA UDI | Class I | Active |
| Aura 300 | DDS-402 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCXS3DDS | FDA UDI | Class II | Active |
| Aura Elite | DDS-505 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCX3DDS | FDA UDI | Class II | Active |
| Aura 300 | DDS-404 | FDA UDI | Class I | Active |
| Aura Lotus | DDS-801 | FDA UDI | Class I | Active |
| Aura 300 | DDS-403 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCX3DDS | FDA UDI | Class II | Active |
| Aura Touch | DDS-105 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCS3DDS | FDA UDI | Class II | Active |
| Aura Elite | DDS-504 | FDA UDI | Class I | Active |
| AuraPrene | DDS-303 | FDA UDI | Class I | Active |
| AuraPrene | DDS-305 | FDA UDI | Class I | Active |
| Aura Touch | DDS-102 | FDA UDI | Class I | Active |
| AuraPrene | DDS-301 | FDA UDI | Class I | Active |
| Aura Elite | DDS-502 | FDA UDI | Class I | Active |
| Aura Touch | DDS-104 | FDA UDI | Class I | Active |
| Aura Lotus | DDS-803 | FDA UDI | Class I | Active |
| Aura Lotus | DDS-805 | FDA UDI | Class I | Active |
| Aura 300 | DDS-405 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCS3DDS | FDA UDI | Class II | Active |
| Aura Elite | DDS-503 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCM3DDS | FDA UDI | Class II | Active |
| Aura Touch | DDS-101 | FDA UDI | Class I | Active |
| AuraPrene | DDS-302 | FDA UDI | Class I | Active |
| Aura Lotus | DDS-802 | FDA UDI | Class I | Active |
| DDS Dental Supplies | DDS-SCXS3DDS | FDA UDI | Class II | Active |
| AuraPrene | DDS-304 | FDA UDI | Class I | Active |
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