(88 days)
The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.
The COMFORTironic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They are designed for use by a trained professional in the field of general dentistry.
The COMFORTarive 200XDA Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by an integrated electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
The COMFORTtronic 4894 dental control unit is a stand-alone system for operating electrically-driven handpieces such as the COMFORTdrive 200XDA. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip/cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist.
The provided documents are 510(k) summaries for two dental devices: the COMFORTdrive 200XDA Handpieces and the COMFORTtronic 4894. These are submissions to the FDA to demonstrate substantial equivalence to existing legally marketed devices, rather than studies designed to prove a device meets specific acceptance criteria through performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from these documents.
The documents focus on:
- Device Name: COMFORTdrive 200XDA Handpieces and COMFORTtronic 4894
- Common Name: Dental Handpiece and Accessories, Operative Dental Unit
- Classification Name: Handpiece, AC-Powered, Dental (21 CFR § 872.4200); Operative Dental Unit and Accessories (21 CFR § 872.6640)
- Intended Use:
- COMFORTdrive 200XDA Handpieces: For removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces by a trained professional in general dentistry.
- COMFORTtronic 4894: To convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces by a trained professional in general dentistry.
- Predicate Devices:
- Substantial Equivalence: Asserted based on identical intended use and similar design, application, function, and technical characteristics to the predicate devices.
There is no data presented in these 510(k) summaries that describes: performance metrics, acceptance criteria, study sizes, ground truth establishment, expert involvement, or any form of comparative effectiveness study. These types of details are typically found in more extensive technical reports or clinical study summaries, which are not part of the provided 510(k) summary text.
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Section III - 510(k) Summary
ffectiveness
SYBRON BER SPECIALTIES
JUN - 6 2008
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person
Date Summary Prepared: March 2008
Device Name:
- Trade Name COMFORTdrive 200XDA Handpieces .
- Common Name Dental Handpiece and Accessories .
- Classification Name Handpiece, AC-Powered, Dental, per 21 CFR § 872.4200 .
Devices for Which Substantial Equivalence is Claimed:
A-dec/W&H, Synea Air-Driven Highspeed Handpieces (K070663) .
Device Description:
The COMFORTarive 200XDA Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by an integrated electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
Intended Use of the Device:
The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.
Substantial Equivalence:
The COMFORTdrive 200XDA Handpieces are substantially equivalent to other legally marketed devices in the United States. The intended use of the devices is identical to that of the predicate. The COMFORTdrive 200XDA Handpieces are substantially equivalent in design, application and function to the Synea Air-Driven Highspeed Handpieces marketed by A-Dec/W&H.
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Section III - 510(k) Summary of Safety and Effectiveness
PECIALTIES
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person
Date Summary Prepared: March 2008
Device Name:
- · Trade Name COMFORTtronic 4894
- Common Name - Operative Dental Unit
- Classification Name Operative Dental Unit and Accessories, per 21 CFR & ● 872.6640
Devices for Which Substantial Equivalence is Claimed:
Device Description:
The COMFORTtronic 4894 dental control unit is a stand-alone system for operating electrically-driven handpieces such as the COMFORTdrive 200XDA. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip/cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist.
Intended Use of the Device:
The COMFORTironic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They are designed for use by a trained professional in the field of general dentistry.
Substantial Equivalence:
The COMFORTtronics 4894 is substantially equivalent to other legally marketed devices in the United States. The COMFORTronic 4894 is substantially equivalent in intended use and technical characteristics to the Optima MX marketed by Bien Air and Sirotorque L marketed by Sirona Dental Systems.
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Indications for Use
510(k) Number (if known):
Device Name: COMFORTdrive 200XDA Handpieces
Indications for Use:
The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.
0806777
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
Kaltenbach & Voigt GmbH C/O Ms. Claudia Ortiz Compliance Manager, Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K080677
Trade/Device Name: COMFORTtronic 4894 Regulation Number: 21 CFR 872.6640 and 872.4200 Regulation Name: Dental Operative Unit and Accessories and Dental Handpiece and Accessories Regulatory Class: I Product Code: EIA, EFB Dated: May 28, 2008 Received: May 29, 2008
Dear Ms. Ortiz:
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.
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Page 2 - Ms. Ortiz
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, 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/industry/support/index.html.
Sincerely yours,
Saite Y. Michael DMD.
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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Indications for Use
510(k) Number (if known): 4080 le 7
Device Name: COMFORTtronic 4894
Indications for Use:
The COMFORTironic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They are designed for use by a trained professional in the field of general dentistry.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Suen Ruster
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.