A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM by A-DEC, INC.

The A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is intended for use in dental treatment procedures. The pneumatically operated sonic device can be used, in conjunction with the appropriate tips, for the removal of supra and subgingival calculus, and teeth cleaning procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding a dental device. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or AI/ML performance study would.

The document is a regulatory approval letter based on "substantial equivalence" to legally marketed predicate devices, not on specific performance metrics or a detailed clinical study demonstrating new or improved efficacy against defined acceptance criteria.

Therefore, I cannot provide the requested information from this document:

A table of acceptance criteria and the reported device performance: Not present. This document is about regulatory clearance based on substantial equivalence, not performance against specific criteria.
Sample size used for the test set and the data provenance: Not present. No clinical or performance study with a test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
Adjudication method for the test set: Not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a sonic scaler handpiece, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a physical dental instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

The document's purpose is to confirm that the A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is "substantially equivalent" to existing devices, allowing it to be marketed. It refers to general controls, registration, labeling, and good manufacturing practices but does not include data from a performance study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 9 2010

Mr. Thomas H. Louisell Regulatory Compliance Manager A-dec, Incorporated 2601 Crestview Drive Newberg, Oregon 97132-9257

Re: K100647

Trade/Device Name: A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment Models ZA-55 LM, ZA-55 L, ZA-55M, ZA55 and SF1LM Regulation Number: 21CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II . Product Code: ELC Dated: June 22, 2010 Received: June 24, 2010 -

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. 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.

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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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A., Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Page of 1

510(k) Number (if known): K100647

Device Name:

A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment Models ZA-55 LM, ZA-55 L, ZA-55M, ZA-55, and SF1LM

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801Subpart D)	✓	OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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Reei Huley for MSR

Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K100647
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Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.