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The AEU-6000-70V and AEU-6000 are drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.

drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.

This document is a 510(k) premarket notification from the FDA regarding the Aseptico AEU-6000-70V and AEU-6000 Implant/Surgical & Endodontic Dental Systems. It is a clearance letter, not a study report, and therefore does not contain the requested information about acceptance criteria or study details proving device performance.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly and has the same intended use. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would have included testing data. However, the clearance letter itself does not detail that testing data.

To answer your questions, one would need to review the original 510(k) submission (K142124) submitted by Aseptico, Incorporated, which is not provided in the prompt.

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