FDA.reportPublic FDA data

ACTILINK™

Primary DI
08800066500245
Brand
ACTILINK™
Company
Plasmapp Co.,Ltd.
Model
ACTILINK mini
Device 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
Published
2022-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066500245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066500245088000665002458800066500245

GMDN Terms#

Term, Definition table
TermDefinition
Plasma sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using vapours (or gases) in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and then packed; a means to introduce the vapour [e.g., hydrogen peroxide (H2O2)] into the chamber; electrodes that are activated to convert the vapour into plasma; a radio-frequency generator; and cycle controls. The device is available in stand-alone (bulk) and tabletop units.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695798956
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800066500306STERILINK™110V2023-07-13
08800066500191STERLINK™CD422021-11-26
08800066500207STERLINK™CT402021-11-26
08800066500313STERILINK™110V2023-07-13
08800066500030STERLINK™STERLOAD2021-11-26
08800066500054STERLINK™FPS-15s Plus2021-11-26
08800066500320STERILINK™110V2023-07-13
08800066500269ACTILINK™ACTILINK reborn2023-02-24
08800066500221STERLINK™Mini-bio2021-12-27
08800066500184STERLINK™BT962021-11-26
08800066500214STERLINK™FR4001002021-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224151496OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
00840481138041LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18