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Power Dental USA, Inc.

US

Last updated September 17, 2026

What Power Dental USA, Inc. makes

Power Dental USA, Inc. manufactures reusable dental instruments for extraction and periodontal procedures, including tooth/root elevators, periodontal curettes, and orthodontic pliers. Their portfolio also includes reusable dental excavators, spatulas, and scissors-like dressing forceps, as well as disposable dental amalgam carriers and tooth extraction forceps.

The company’s devices are regulated under FDA’s 510(k) clearance process, with products classified as either Class I or Class II. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.

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 Power Dental USA, Inc. manufacture?

Power Dental USA, Inc. specializes in reusable dental instruments primarily used for extraction and periodontal procedures. Their product line includes devices like dental elevators for removing teeth or roots, periodontal curettes for cleaning below the gumline, orthodontic pliers for wire adjustments, and dental excavators for removing decay. They also produce reusable dental spatulas and scissors-like dressing forceps, along with disposable dental amalgam carriers and tooth extraction forceps. These instruments are designed to assist in routine and specialized dental treatments.

Where is Power Dental USA, Inc. based?

Power Dental USA, Inc. is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, which governs its product development, manufacturing, and compliance processes.

Are Power Dental USA, Inc.’s devices listed in any regulatory registries?

Yes, Power Dental USA, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures that each device has a unique code for identification, tracking, and compliance purposes, which is critical for regulatory transparency and traceability in the U.S. market.

How are Power Dental USA, Inc.’s devices classified under FDA regulations?

Power Dental USA, Inc.’s devices fall under two classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as the 510(k) clearance process, which ensures these devices meet FDA requirements before entering the market.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
2809 Barney Ct, McHenry, IL, 60051
Website
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LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3003969055
DUNS Number
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Catalogue (3014)

Page 24 of 61
DeviceModel / ReferenceRegistriesClassStatus
Power Dental USA 1415BT
FDA UDI
Class IActive
Power Dental USA 4613
FDA UDI
Class IActive
Power Dental USA KIMS-GRY
FDA UDI
Class IActive
Power Dental USA 6531
FDA UDI
Class IActive
Power Dental USA 4830
FDA UDI
Class IUnknown
Power Dental USA 1709
FDA UDI
Class IActive
Power Dental USA 3110S
FDA UDI
Class IActive
Power Dental USA 5512
FDA UDI
Class IActive
Power Dental USA 8100-4
FDA UDI
Class IActive
Power Dental USA 5402
FDA UDI
Class IActive
Power Dental USA 5311
FDA UDI
Class IActive
Garg GIMP
FDA UDI
Class IActive
Power Dental U.S.A., Inc. N1607BE
FDA UDI
Class IActive
Power Dental USA 6433N
FDA UDI
Class IActive
Power Dental USA 2055S
FDA UDI
Class IActive
Power Dental USA 1102
FDA UDI
Class IActive
Power Dental USA 4927
FDA UDI
Class IActive
Power Dental USA 5872
FDA UDI
Class IActive
Power Dental USA 4981
FDA UDI
Class IActive
Power Dental USA 1611SR
FDA UDI
Class IActive
Power Dental USA 6534
FDA UDI
Class IActive
Power Dental USA 6906
FDA UDI
Class IActive
Power Dental USA 2070S
FDA UDI
Class IActive
Power Dental USA 1958
FDA UDI
Class IActive
Power Dental USA 7239
FDA UDI
Class IActive
Power Dental USA 3764
FDA UDI
Class IActive
Power Dental U.S.A., Inc. N5034-2
FDA UDI
Class IUnknown
Power Dental USA 4906
FDA UDI
Class IActive
Power Dental USA 7819
FDA UDI
Class IActive
Power Dental USA 5891
FDA UDI
Class IActive
Power Dental USA 7425
FDA UDI
Class IActive
Power Dental USA 5122P
FDA UDI
Class IActive
Power Dental USA 1277
FDA UDI
Class IUnknown
Power Dental USA 4954
FDA UDI
Class IActive
Power Dental USA 4030S
FDA UDI
Class IActive
Power Dental USA 1973
FDA UDI
Class IActive
Power Dental USA 7819-2
FDA UDI
Class IActive
Power Dental USA 3108S-6EZ
FDA UDI
Class IActive
Power Dental USA 4913
FDA UDI
Class IActive
Power Dental USA 5889
FDA UDI
Class IActive
Power Dental U.S.A., Inc. N7233
FDA UDI
Class IActive
Power Dental USA 2920
FDA UDI
Class IActive
Power Dental USA 3531
FDA UDI
Class IActive
Garg GCON
FDA UDI
Class IActive
Power Dental USA 1272
FDA UDI
Class IUnknown
Power Dental USA 2801T
FDA UDI
Class IActive
Power Dental USA 3402
FDA UDI
Class IActive
Power Dental USA 3410
FDA UDI
Class IActive
Power Dental USA 2035
FDA UDI
Class IActive
Power Dental USA 1208
FDA UDI
Class IActive

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