The Sirona SIROAIR L Scaler (SIROAIR) consists of a handpiece, quick-action coupling and accessories for changing and cleaning the instrument tips. The SIROAIR handpiece connects to an air-driven handpiece hose on a dental operative unit. The power delivered to the handpiece is adjusted via a control ring located on the handpiece. Three types of couplings are available. Two types contain a halogen lamp and a control ring to adjust the water flow. The third type lacks the lamp and has a fixed water flow. A variety of instrument tips (SIROTIPS) are available that are designed for specific dental procedures and to access particular areas of the mouth.

AI/ML Overview

This 510(k) submission for the SIROAIR L Air Scaler does not contain the specific acceptance criteria or details of a study proving the device meets said criteria.

The provided document is a 510(k) summary, which outlines the device's description, intended use, predicate devices, and a determination of substantial equivalence by the FDA. It does not include performance data or clinical study results in the level of detail requested.

Therefore, I cannot provide the requested information, which would typically be found in a more comprehensive clinical study report or performance testing documentation submitted to the FDA, but not in the public 510(k) summary.

Specifically, the following information is missing from the provided text:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth experts are mentioned.
Adjudication method: Not applicable as no test set or ground truth establishment is described.
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 applicable. This device is an air-powered scaler, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an air-powered scaler, not an algorithm.
The type of ground truth used: Not applicable as no ground truth is described.
The sample size for the training set: Not applicable to this type of device.
How the ground truth for the training set was established: Not applicable to this type of device.

The document primarily focuses on establishing substantial equivalence to a predicate device (W&H Corsair Scaler K944714) based on similar design, intended use, and function for calculus removal. It does not present new performance data or clinical study results for the SIROAIR L Air Scaler.

Summary

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Ko33812

510(k) Summary for SIROAIR L Air Scaler

1. SPONSOR

Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany

Contact Person: Fritz Kolle Regulatory Manager

December 5, 2003 Date Prepared:

Device Name 2.

Proprietary Name:	SIROAIR L Air Scaler
Common/Usual Name:	Air-powered Scaler
Classification Name:	Dental handpiece and accessories

3. Predicate Devices

W&H Corsair Scaler (K944714)

4. INTENDED USE

The Sirona Dental Systems SIROAIR L Air Scaler is an air-powered scaler intended for use in calculus removal (subgingival and supragingival).

ડ. DEVICE DESCRIPTION

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Three types of couplings are available. Two types contain a halogen lamp and a control ring to adjust the water flow. The third type lacks the lamp and has a fixed water flow.

A variety of instrument tips (SIROTIPS) are available that are designed for specific dental procedures and to access particular areas of the mouth.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

Both the proposed SIROAIR and the predicate Corsair device are air-powered scalers used for removal of calculus deposits during dental cleaning procedures. The overall designs of the proposed SIROAIR and predicate Corsair Scaler are similar. Both the proposed and predicate scalers offer a variety of instrument tips specifically designed for performing the indicated dental procedures and accessing teeth in specific areas of the mouth.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2004

Sirona Dental Systems GmbH C/O Ms. Mary McNamara-Cullinanc Medical Devices Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K033812 Trade/Device Name: SIROAIR L Air Scaler Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: Deccmber 5, 2003 Received: December 9, 2003

Dear Ms. McNamara-Cullinane:

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 received above and hat in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendne ochinetes prices 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 approval approvisions 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 (1 Mr), it may of cash be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can over butlish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. McNamara-Cullinane

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be advisor that 1 Dr. o febuation that your device complies with other requirements mean that FDA nas made a deceminaremations administered by other Federal agencies. of the Act of ally I edetal states requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 877), adality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in the qualify ion 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) I mis letter will and w you ve cogni finding of substantial equivalence of your device to a premarket notifed fredicate 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), If you desire specific acrise of Compliance at (301) 594-4613. 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 may ovaill outer galleralacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clu

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

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510(k) Number (if known):

Device Name: SIROAIR L Air Scaler

Indications for Use:

The SIROAIR L Air Scaler is an air-powered scaler intended for use in calculus removal (subgingival and supragingival).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

510(k) Number: K053362

Prescription Use ] (Per 21 CFR 801.109) ાર

Over-The-Counter Usc

(Optional Format 1-2-96)

Sirona Dental Systems GmbH 510(k) SIROAIR L Air Scaler

December 5, 2003

Regulation Number and Section

§ 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.