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Sign in to claim this brandWhat POINTIMPLANT Co., Ltd. makes
PointImplant Co., Ltd. manufactures dental implant components, including permanent and temporary preformed suprastructures, single-use precision attachments for scanning and simulation, and reusable dental drill bits. Their portfolio also covers two-piece endosteal dental implants, reusable abutment screw analogs, and intraoral-scanning abutment analogs. Surgical screwdrivers and healing abutments are also part of their product range.
The company’s devices are classified under FDA regulations as Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. These items are intended for dental applications and are subject to 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 PointImplant Co., Ltd. manufacture?
PointImplant Co., Ltd. specializes in dental implant components and related accessories. Their products include permanent and temporary preformed suprastructures for dental implants, single-use precision attachments like scanning simulators and intraoral-scanning abutment analogs, reusable dental drill bits, and two-piece endosteal dental implants. They also produce reusable tools such as surgical screwdrivers and abutment screw analogs, as well as healing abutments. These devices are designed to support dental restoration procedures.
Where is PointImplant Co., Ltd. based, and what regulatory database lists their devices?
PointImplant Co., Ltd. is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of their products under FDA regulations.
How are PointImplant Co., Ltd.’s devices classified under FDA regulations?
PointImplant Co., Ltd.’s devices are classified under the FDA’s medical device regulations as either Class I or Class II. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it. For example, reusable tools like drill bits and screwdrivers are typically Class II due to their critical role in surgical precision, while some single-use components may fall under Class I if they pose lower risk. Classification determines the regulatory pathway for authorization.
What does it mean for PointImplant Co., Ltd.’s devices to be listed in the FDA’s UDI database?
Listing in the FDA’s Unique Device Identifier (UDI) database means that each of PointImplant Co., Ltd.’s devices has been assigned a unique code to ensure traceability and identification throughout their lifecycle. This system helps healthcare providers, regulators, and manufacturers track devices for safety monitoring, recalls, and compliance with U.S. medical device laws. It also supports transparency in the supply chain, ensuring that only authorized products enter the market.
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
- 695333960
Catalogue (1771)
Page 36 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pick-Up Impression Coping | OSICPM4511H | FDA UDI | Class I | Active |
| Fixture | POF4507 | FDA UDI | Class II | Active |
| Pick-Up Impression Coping | PIIC4812 | FDA UDI | Class I | Active |
| Transfer Impression Coping | OSICT7014H | FDA UDI | Class I | Active |
| Cap | OSSPC404 | FDA UDI | Class II | Active |
| Pick-Up Impression Coping | PIICP6507NP | FDA UDI | Class I | Active |
| Pick-Up Impression Coping | OSICPM4517NP | FDA UDI | Class I | Active |
| Solid Abutment | OSSA4075P | FDA UDI | Class II | Active |
| Cemented Abutment | OSCA5051HT | FDA UDI | Class II | Active |
| Angled Abutment | OSAA5002AP | FDA UDI | Class II | Active |
| Cemented Abutment | OSCA5053NP | FDA UDI | Class II | Active |
| Transfer Impression Coping | OSICTM4516H | FDA UDI | Class I | Active |
| Ball Abutment Driver | OBDT2400L | FDA UDI | Class I | Active |
| Cemented Abutment | OSCA4551H | FDA UDI | Class II | Active |
| Solid Abutment | OSSAM4052TP | FDA UDI | Class II | Active |
| Bite Impression Coping Cap | OBICC | FDA UDI | Class I | Active |
| Pick-Up Impression Coping | OSICP6011H | FDA UDI | Class I | Active |
| Hex Driver | OTDS1200 | FDA UDI | Class I | Active |
| Solid Abutment | OSSAM4041TP | FDA UDI | Class II | Active |
| Solid Abutment | OSSA4052P | FDA UDI | Class II | Active |
| Cemented Abutment | OSCA5073NP | FDA UDI | Class II | Active |
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