(76 days)
Not Found
No
The description details a mechanical air-powered scaler with adjustable settings and various tips. There is no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is intended for calculus removal, which is a therapeutic procedure to improve or maintain a patient's health.
No
The device is an air-powered scaler used for calculus removal, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of a handpiece, quick-action coupling, and accessories, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Sirona Dental Systems SIROAIR L Air Scaler is a dental tool used directly in the mouth to remove calculus. It operates mechanically using air power and water.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It performs a physical procedure within the oral cavity.
Therefore, based on its intended use and description, the Sirona Dental Systems SIROAIR L Air Scaler is a dental instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sirona Dental Systems SIROAIR L Air Scaler is an air-powered scaler intended for use in calculus removal (subgingival and supragingival).
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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.
1
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.
2
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.
3
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
4
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