(120 days)
No
The device description focuses on mechanical movement and gearing, with no mention of AI/ML terms or functions.
Yes
The device is intended for mechanical interproximal enamel reduction (stripping, slenderizing), which is a therapeutic procedure performed on a patient's teeth.
No
The device is described as a dental handpiece attachment intended for mechanical interproximal enamel reduction, which is a therapeutic rather than a diagnostic procedure. It performs a physical alteration (stripping, slenderizing) of the enamel.
No
The device description clearly describes a physical dental handpiece attachment with mechanical components (gearing elements, head gear) that converts rotational movement into oscillating movement. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The "KOMET - OS30" is a mechanical dental handpiece attachment used for physically reducing interproximal enamel. It operates on the teeth directly within the mouth.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is purely mechanical and performed directly on the anatomical site.
Therefore, the intended use and device description clearly indicate a mechanical dental tool, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The dental contra-angle handpiece "KOMET - OS30" is intended for mechanical interproximal enamel reduction (stripping, slenderizing) in use of an oscillating movement.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The dental handpiece attachment "KOMET - OS30" is a drive, in order to enable the mechanical interproximal enamel reduction by means of the oscillating movement of the attached "KOMET - OS Discs". "OS30" is provided with a coupling system according to ISO 3964, allowing the handpiece's attachment onto a corresponding dental motor. The handpiece's gearing elements transmit the motor's rotational movement up to the integrated head gear, where this movement is converted into an oscillating one. The "OS Disc", chucked in the said head gear, oscillates in an angle of 30°, depending on the motor's speed with max. 5.000 oscillations/min.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing results demonstrate substantially equivalence
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.
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
| | 510(k) Contra-Angle Handpiece
"KOMET - OS30" | Section 5
Page 1 of 1 | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------|--|
| 510(k) SUMMARY | | | JUN 30 200 | |
| Applicant and Owner | W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strasse 53
A - 5111 Buermoos - Austria
Tel.: 0043 -6274 / 6236 -297
Fax: 0043 -6274 / 6236 -234 | | | |
| Contact Person | Johann Georg SCHARL | | | |
| Date of Preparation | February 24th, 2009 | | | |
| Device Name | Contra-Angle Handpiece "KOMET - OS30" | | | |
| Classification Name | Handpiece, Air-Powered, Dental | | | |
| Regulation Number | 21 CFR872.4200 | | | |
| Product Code | EFB | | | |
| Predicate Devices | Dentsply International:
"Interproximal Reduction System", K053368 | | | |
| | A-dec Incorporated: | | | |
| | "A-dec/W&H Synea Profin Reciprocating Contra-Angle | | | |
| | Handpiece Attachment WA-67...", K082827 | | | |
| Device Description | The dental handpiece attachment "KOMET - OS30" is a drive, in
order to enable the mechanical interproximal enamel reduction
by means of the oscillating movement of the attached "KOMET -
OS Discs". "OS30" is provided with a coupling system according
to ISO 3964, allowing the handpiece's attachment onto a
corresponding dental motor. The handpiece's gearing elements
transmit the motor's rotational movement up to the integrated
head gear, where this movement is converted into an oscillating
one. The "OS Disc", chucked in the said head gear, oscillates in
an angle of 30°, depending on the motor's speed with max.
5.000 oscillations/min. | | | |
| Intended Use: | The dental contra-angle handpiece "KOMET - OS30" is intended
for mechanical interproximal enamel reduction (stripping,
slenderizing) in use of an oscillating movement. | | | |
| Technological
Characteristics | The handpiece "KOMET - OS30" represents a further variant of
W&H's dental contra-angle handpieces series Synea, which
already have been cleared by A-dec Inc. under the 510(k)
numbers K993526, K070663 and just recently K053368.
While the main technical characteristics have been retained
unchanged, the new product's transmission elements prompt the
chucked tool to move in an oscillating manner. | | | |
| Comparison of the
device to the predicate
device | The intended use, technological characteristics and performance
parameter are very similar to the predicate device cleared by
Dentsply International. The technological characteristics and the
materials furthermore are very similar to ones of the products
cleared by A-dec Inc.
The new device is substantially equivalent to the predicate
devices. | | | |
| Performance Testing | Bench testing results demonstrate substantially equivalence | | | |
| Clinical Testing | Clinical data were not needed for this new product. | | | |
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Feb. 4th, 2009
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1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and three wing segments. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN 3 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Johann Georg Scharl Regulatory Affairs Manager W& H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53 Buermoss Salzburg A-5111 AUSTRIA
Re: K090548
Trade/Device Name: Contra-Angle Handpiece "KOMET-OS30" Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 23, 2009 Received: June 25, 2009
Dear Mr. Scharl:
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 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.
2
Page 2- Mr. Scharl
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 (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Susan Cunne
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| W&H | 510(k) Contra-Angle Handpiece
"KOMET - OS30" | Section 4
| Page 1 of 1 |
|---|
| ------------- |
Indications for Use
Device Name:
Contra-Angle Handpiece "KOMET - OS30"
Indication for Use:
The dental contra-angle handpiece "KOMET - OS30" is
intended for mechanical interproximal enamel reduction
(stripping, slenderizing) in use of an oscillating movement
| Labels | Values |
|---|---|
| Prescription Use | X |
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over The Counter Use | |
| (Part 21 CFR 807 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K090548
Feb. 4th, 2009
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