Identity
- Trade Name
- ACTILINK™ FDA UDI
- Generic Name
- Plasma sterilizer FDA UDI
- Device Name
- The ACTILINK mini is indicated for removing the hydrocarbon impurities on the surface of the endosseosous dental implants. According to the test results, it is verified that the plasma enhanced vacuuming flow can efficiently clean the hydrocarbon impurities on the implant surface. The ACTILINK mini can process: • Dental implant fixtures made of titanium or titanium alloy FDA UDI
- Model / Reference
- ACTILINK mini FDA UDI
- Description
- The ACTILINK mini is indicated for removing the hydrocarbon impurities on the surface of the endosseosous dental implants. According to the test results, it is verified that the plasma enhanced vacuuming flow can efficiently clean the hydrocarbon impurities on the implant surface. The ACTILINK mini can process: • Dental implant fixtures made of titanium or titanium alloy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066500245 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Plasma sterilizer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Plasma sterilizer
Actilink™ by Plasmapp Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd.
Sources (1)
- FDA UDI c84e2d6b-8fff-4915-937c-8ba58c2c667f 34 fields · synced May 31, 2026