DELSONIC 2000

K014238 · Deldent , Ltd. · ELC · Jan 24, 2002 · Dental

Device Facts

• Record ID: K014238
• Device Name: DELSONIC 2000
• Applicant: Deldent , Ltd.
• Product Code: ELC · Dental
• Decision Date: Jan 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system removal or light to tight to time for each scaling insert.

Device Story

Delsonic 2000 is a 29KHz ultrasonic dental scaler; used by dental professionals for removal of calculus and plaque. Device operates via ultrasonic vibration of scaling inserts to mechanically dislodge deposits from tooth surfaces. Used in clinical dental settings. Output is mechanical vibration; aids clinician in periodontal cleaning and hygiene procedures. Benefits patient through efficient removal of dental plaque and calculus.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

29KHz ultrasonic scaling system. Form factor is a dental scaler unit. Operates via ultrasonic energy for mechanical deposit removal.

Indications for Use

Indicated for the removal of light to heavy calculus and plaque in dental patients.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

Mr. Alan Edel Joint C.E.O Deldent Limited 19 Keren Kayemet Street Petach, Tikvah, ISRAEL

Re: K014238

Trade/Device Name: Delsonic 2000 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 27, 2001 Received: December 26, 2001

Dear Mr. Edel:

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.

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

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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regareents, including, but not limited to: registration You must comply with an the Act 3 requirements and 1); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 807), laceming (21 cms (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality by occases (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 I his letter will and w you to begin manteening your substantial equivalence of your device to 310(K) premarket nonication: The I Brivaina 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 II you desire specific ad rios for your for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 607.10 103 ... Additionally, for questions on the promotion and
Office of Compliance at [phone]. Additionally, for questions on the promo Office of Comphance at (301) 591 - 1231 - 123 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 6 - - - 6 - advertising of your as note the regulation entitled, "Misbranding by reference to premarket Also, prease note the rogulation one other general information on your responsibilities under notification (ZTCFR Part 00197). Gailer Jan 2019 - 12:10 PM (2019) 142 - 667 the Act may be obtained from the Driver - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## K014238

## LABELING

Page 1 of 1

510(k) Number (if known): _ Unknown

Delsonic 2000 Ultrasonic Scaler Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable The Delsonic 2000 Ultrasonic Scaler 15 Interded This 29KHz Ultrasonic system
removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system
removal of light to h removal or light to tight to time for each scaling insert.

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NEWS OF NOT WRITE DELOW - NEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

سا Prescription Use_ Per 21 CFR801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Susan Ryan

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devicess 510(k) Number _