(127 days)
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No
The summary describes a mechanical drive system for dental procedures with irrigation and user controls, with no mention of AI or ML.
Yes
The device is described as a "drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures," and specifically mentions "drilling during osteotomy preparation and implant placement, or endodontic therapy." These are medical procedures performed on patients, indicating a therapeutic purpose.
No
The device is described as a drive system for instruments and tools used in dentistry, designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy. Its function is to perform a physical action (drilling), not to diagnose a condition or disease.
No
The device is described as a "drive system for instruments and tools used in dentistry," which inherently implies hardware components for driving and controlling instruments. The description of "irrigation supply" and "user controls" further supports the presence of physical hardware.
Based on the provided information, the AEU-700L-70V is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures." This describes a device used on a patient during a procedure, not a device used to test samples from a patient outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The AEU-700L-70V is a surgical/procedural device used directly in the dental setting.
N/A
Intended Use / Indications for Use
The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.
Product codes
EKX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of a human figure with three faces in profile, one behind the other. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2015
Aseptico, Inc. Ms. Cherie Tregoning Regulatory Affairs Specialist 8333 216th Street South East Woodinville Washington, 98072
Re: K150129
Trade/Device Name: AEU-7000L-70V Implant/Endodontic Dental System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: April 24, 2015 Received: April 29, 2015
Dear Ms. Tregoning:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Aseptico, a company that specializes in advancing dental technology. The logo features the company name in a stylized font, with a blue swirl design to the left. Contact information is listed to the right of the logo, including the phone number 800.426.5913, fax number 360.668.8722, and website www.aseptico.com.
Indications for Use
Device Name: AEU-7000L-70V Implant / Endodontic Dental System
Indications for Use:
The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.
Prescription Use _ X
And/Or
Over-The-Counter Use (21CFR 801 Subpart C)