(120 days)
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No
The 510(k) summary describes a standard air-driven dental handpiece and attachment with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device is used for dental procedures like removing material, preparing cavities, and polishing teeth, which are restorative rather than therapeutic in the medical sense of treating a disease or disorder.
No
Explanation: The provided text describes the device's function as removing dental material, preparing cavities and crowns, and polishing teeth. These are all interventional or treatment-related procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it is an "air-powered dental device" and an "Handpiece Attachment powered by either an air-motor or electric motor," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The A-dec/W&H Alegra Air-Driven Highspeed Handpiece and Handpiece Attachment are described as air-powered or motor-powered dental devices used for mechanical procedures on teeth (removing material, preparing cavities, polishing, etc.).
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device directly interacts with the tooth structure.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental handpiece intended for general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or electric motor and is intended for general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
Product codes
EFB
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three talons, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2009
Mr. Thomas H. Louisell Regulatory Compliance Manager A-dec, Incorporated 2601 Crestview Drive Newberg, Oregon 97132-9257
Re: K082716
Trade/Device Name: A-dec/W&H Alegra Air-Driven Highspeed Handpiece, Models TE-98, TE-97 A-dec/W&H Alegra Handpiece Attachment, Models WE-99 LED G, WE-66 LED G, WE-57 LED G, WE-56 LED G, HE-43A
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece and Accessories
Regulatory Class: II
Product Code: EFB
Dated: January 6, 2009
Received: January 7, 2009
ﺗﮭ
Dear Mr. Louisell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
Page 2 - Mr. Louisell
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sman Punner
Ginette Y. Michaud, M.D. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ਪ੍ਰ
2
INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known):
Device Name:
A-dec/W&H Alegra Air-Driven Highspeed Handpiece, models TE-98, TE-97 A doo/W&H Alegra Handpiece Attachment, models WE-99 LED G, WE-66 LED G, WE-57 LED G, WE-56 LED G, HE-43 A
Indications For Use:
The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental The A dool North Ribgia Mira Listing This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or The A door War PAlogra Hariageneral dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Prescription Use 4 (Per 21 CFR 801Subpart D)
| OR | Susan Runne |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | |
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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