ENGLER 25K SERIES ULTRASONIC INSERTS

K122748 · Engler Engineering Corp. · ELC · Jun 11, 2013 · Dental

Device Facts

• Record ID: K122748
• Device Name: ENGLER 25K SERIES ULTRASONIC INSERTS
• Applicant: Engler Engineering Corp.
• Product Code: ELC · Dental
• Decision Date: Jun 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market. This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.

Device Story

The 25K Series Insert is a dental instrument designed for use with existing 25K ultrasonic dental handpieces. Operated by dental professionals or authorized technicians, the device facilitates teeth cleaning through ultrasonic scaling. It functions as a mechanical insert that converts electrical energy from the handpiece into ultrasonic vibrations to remove dental calculus and plaque. The device is used in clinical dental settings. It does not involve software or complex algorithms; it is a mechanical accessory for standard ultrasonic scaling equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical ultrasonic scaler insert designed for 25K frequency handpieces. Operates via ultrasonic vibration for dental prophylaxis. No software, electronics, or connectivity features.

Indications for Use

Indicated for dental professionals and authorized technicians for teeth cleaning via ultrasonic scaling. Compatible with any approved 25K ultrasonic dental handpiece. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## June 11, 2013

Mr. Joel Katz Engler Engineering Corporation 1099 East 47th Street HIALEAH FL 33013

Re: K122748

Trade/Device Name: 25K Series Insert Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 30, 2013 Received: May 29, 2013

Dear Mr. Katz:

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 (Act) that do not require approval 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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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 devicerelated 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely vours.

Susan Runner DDS, MA Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division 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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## 长122748

Engler Engineering Corporation 1099 East 47 Street Hialeah, FL 33013

## Indication For Use

REF: 510(k) Number K122748/S001

`Device Name: 25K Series Insert

Indications for Use:

This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market.

This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.

Andrew I. Steen
2013.06.07 12:21:42 -04'00'

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

**510(k) Number:** K122748