(118 days)
Not Found
Not Found
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 in medical devices.
No
The device is a dental handpiece used for various dental procedures, which are generally considered treatments rather than therapies. Therapeutic devices are typically used to treat diseases or health conditions, and while dental procedures treat conditions like cavities, the device itself is a tool for these procedures rather than a therapeutic agent.
No
The device is described as an air-powered dental handpiece used for procedures like removing carious material, cavity preparation, and polishing teeth. These are interventional and treatment-related functions, not diagnostic ones.
No
The device description clearly states it is an "air-powered dental handpiece" and an "Handpiece Attachment powered by either an air-motor or electric micromotor," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used directly on the patient's teeth for procedures like removing material, preparing cavities, and polishing. This is a direct clinical intervention, not a test performed on a sample outside the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The description of the A-dec/W&H Synea Handpiece aligns with a standard dental tool used for mechanical procedures within the mouth, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The A-dec/W&H Synea Air-Driven Highspeed Handpiece is an air-powered dental handpiece for use in 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 Synea Handpiece Attachment is powered by either an air-motor or electric micromotor for use in 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
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general dentistry
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas H. Louisell Regulatory Compliance Manager A-dec. Incorporated 2601 Crestview Drive Newberg, Oregon 97132
JUL - 5 2007
Re: K070663
Trade/Device Name: A-dec/W&H Synea Air-Driven Highspeed Handpiece, Models TA-98, TA-97 A-dec/W&H Synea Handpiece Attachment, Models WA-99LT, WA-86LT, WA-66LT, WA-56LT, HA-43LT
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 26, 2007 Received: June 29, 2007
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 (OS) 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Sutte Y. Michael Ond.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
Page -1
510(k) Number (if known):
Device Name:
A-dec/W&H Synea Air-Driven Highspeed Handpiece, models TA-98, TA-97 A-decM&H Synea Handpiece Attachment, models WA-99LT, WA-86LT, WA-66LT, WA-56LT, HA-43LT
Indications For Use:
The A-dec/W&H Synea Air-Driven Highspeed Handpiece is an air-powered dental handpiece for use in 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 Synea Handpiece Attachment is powered by either an air-motor or electric micromotor for use in 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 2 (Per 21 CFR 801Subpart D)
OR Over-The-Counter Use
21 CFR 801 Subpart C)
Sistelli Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC70663