(164 days)
Not Found
No
The summary describes a mechanical dental handpiece powered by pneumatic pressure, with no mention of software, data processing, or AI/ML terms.
No
The device is described as a dental instrument for removing carious material and preparing teeth, which falls under the category of surgical or diagnostic tools, not therapeutic. Its function is to alter or remove tissue, not cure or alleviate a disease or condition in a therapeutic sense.
No
Explanation: The device is described as being for "removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces," which are all treatment procedures, not diagnostic ones. It is a dental instrument used for restorative and preparation purposes.
No
The device description explicitly states it is a dental instrument powered by pneumatic pressure and is re-usable hardware that can be sterilized. This indicates it is a physical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Century 105C Handpieces are dental instruments used directly on the patient's teeth and restoration surfaces for procedures like removing decay, preparing cavities, and shaping teeth. They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly describes procedures performed in vivo (on a living organism), not in vitro (in a lab setting).
Therefore, based on the provided information, the Century 105C Handpieces are dental instruments for direct patient care, not IVDs.
N/A
Intended Use / Indications for Use
The Century 105C 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.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Century 105C Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by pneumatic pressure on a rotor with roller bearings. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
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
trained professional in the field of general dentistry.
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)
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
Image /page/0/Picture/0 description: The image shows the logo for "Sybron Dental Specialties". The logo is in black and white. The text is in a bold, serif font. There is a curved line above the text.
KU9334//
Section III - 510(k) Summary of Safety and Effectiveness
APR - 5 2010
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person Phone number: 714.516.7981 Fax number: 714.516.7488
Date Summary Prepared: October 19, 2009
Device Name:
- Trade Name KaVo Century 105C ●
- . Common Name - Dental Handpiece and Accessories
- Classification Name Handpiece, Air-powered, Dental, per 21 CFR 872.4200 .
Devices for Which Substantial Equivalence is Claimed:
- Kaltenbach & Voigt GmbH, SUPERtorque Air-Driven Highspeed Handpieces ● (K073478)
Device Description:
The Century 105C Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by pneumatic pressure on a rotor with roller bearings. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
Intended Use of the Device:
The Century 105C 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 Century 105C 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 Century 105C Handpieces are substantially equivalent in design, application and function to the SUPERtroque Air-Driven Highspeed Handpieces marketed by Kaltenbach & Voigt GmbH.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Claudia Ortiz Compliance Director & Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867 APR - 5 2010
Re: K093341 Trade/Device Name: Century 105C Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: March 26, 2010 Received: March 30, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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- 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I - Indications for Use
Indications for Use
510(k) Number (if known):
Device Name: Century 105C
Indications for Use:
The Century 105C 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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) ivision Division of Anesthesiology, General Hospital infection Control, Dental Devices
| 510(k) Number: | K093341 |
|---|---|
| ---------------- | --------- |