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Sign in to claim this brandPac-Dent International, Inc.
US
Last updated May 23, 2026
What Pac-Dent International, Inc. makes
Pac-Dent International, Inc. manufactures dental composite resins, silicone impression materials, temporary crowns and bridges, cryogenic dental sprays, and disposable dental bibs. Their portfolio includes restorative and impression materials used in dental procedures, as well as protective and cooling agents for patient comfort and treatment efficiency.
The company’s devices are regulated under FDA Class II and Class U classifications, with authorisations recorded via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. Products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
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 Pac-Dent International, Inc. manufacture?
Pac-Dent International, Inc. specializes in dental devices, including dental composite resins (used for fillings and restorations), silicone dental impression materials (for creating molds of teeth), temporary dental crowns and bridges (for interim tooth coverage), cryogenic sprays (for cooling during procedures), and disposable dental bibs (for patient isolation). These products support restorative, diagnostic, and procedural needs in dentistry.
Where is Pac-Dent International, Inc. based, and how does that affect its regulatory oversight?
Pac-Dent International, Inc. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies its products as either Class II (moderate risk, requiring special controls) or Class U (unclassified, typically low risk), with regulatory authorisations documented through 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device regulations.
Which regulatory registries or databases list Pac-Dent International’s devices?
Pac-Dent International’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorised devices, their classifications, and compliance with U.S. regulatory requirements. The UDI system, in particular, provides a standardized way to identify devices throughout their lifecycle.
How are Pac-Dent International’s devices classified by the FDA, and why does this matter?
The FDA classifies Pac-Dent International’s devices as either Class II or Class U. Class II devices require additional controls beyond general controls (like labeling or performance standards) due to moderate risk, while Class U devices are unclassified but typically low-risk. This classification determines the regulatory pathway for authorisation—such as 510(k) submissions—and ensures appropriate oversight based on the device’s intended use and potential risks in dental procedures.
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
- 959077454
Catalogue (184)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pac-Dent | DX-825 | FDA UDI | Class II | Active |
| Pac-Dent | 8015 | FDA UDI | Class II | Active |
| Pac-Dent | P3740 | FDA UDI | Class II | Active |
| Pac-Dent | 8102 | FDA UDI | Class II | Active |
| Pac-Dent | 8210 | FDA UDI | Class II | Active |
| Pac-Dent | 8116 | FDA UDI | Class II | Active |
| Pac-Dent | PD-150 | FDA UDI | Class II | Active |
| Pac-Dent | DX-406 | FDA UDI | Class II | Active |
| Pac-Dent | 8203 | FDA UDI | Class II | Active |
| Pac-Dent | 101A | FDA UDI | Class II | Active |
| Pac-Dent | 8020 | FDA UDI | Class II | Active |
| Pac-Dent | PD-7689 | FDA UDI | Class II | Active |
| Pac-Dent | PD-187 | FDA UDI | Class II | Active |
| Pac-Dent | 8214 | FDA UDI | Class II | Active |
| Pac-Dent | PD-7682 | FDA UDI | Class II | Active |
| Pac-Dent | 8216 | FDA UDI | Class II | Active |
| Pac-Dent | PD-7706 | FDA UDI | Class II | Active |
| Pac-Dent | 8016 | FDA UDI | Class II | Active |
| Pac-Dent | PD-211-25 | FDA UDI | Class II | Active |
| Pac-Dent | DX-405 | FDA UDI | Class II | Active |
| Pac-Dent | 8201 | FDA UDI | Class II | Active |
| Pac-Dent | 102 | FDA UDI | Class II | Active |
| Pac-Dent | 8204 | FDA UDI | Class II | Active |
| Pac-Dent | 8003 | FDA UDI | Class II | Active |
| Pac-Dent | 8101 | FDA UDI | Class II | Active |
| PacEndo EDTA | K153528 | FDA 510(k) | U | Active |
| Elements | K151150 | FDA 510(k) | Class II | Active |
| PacEndo Chlorhexidine | K160577 | FDA 510(k) | U | Active |
| Profluoro Fluoride Varnish | K141422 | FDA 510(k) | Class II | Active |
| Pacseal Pit & Fissure Sealant | K141717 | FDA 510(k) | Class II | Active |
| Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | K151123 | FDA 510(k) | Class II | Active |
| GingiDent Gingival Retraction Paste | K162662 | FDA 510(k) | U | Active |
| Optiflow Ii Flowable Composite, Lc | K130672 | FDA 510(k) | Class II | Active |
| PacEndo Sodium Hyprochlorite | K151852 | FDA 510(k) | U | Active |
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