(87 days)
KAVO
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use are consistent with traditional mechanical dental attachments.
No
The device is used for drilling, preparation, disking, and polishing of dental cavities and crowns, which are procedures that modify a body part for therapeutic purposes (restoration). However, it is a tool used by a professional to perform a therapeutic act, not a therapeutic device itself that directly treats a condition or restores health through its own mechanism. It's an accessory to a motor used in a therapeutic procedure.
No
The device, a low-speed dental attachment, is described for use in drilling, preparation, disking, and polishing of dental cavities for restoration. These are treatment and preparation procedures, not diagnostic ones.
No
The device description explicitly states it is a dental attachment that affixes to a low speed dental motor, indicating it is a physical hardware component.
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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a low speed dental attachment used intraorally (inside the mouth) for procedures like drilling, preparing cavities, polishing, etc. These are direct interventions on the patient's body, not tests performed on specimens.
The device description and intended use are consistent with a standard dental tool used for direct patient care, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.
Product codes
EGS
Device Description
Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraorally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals
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)
Star, Midwest, KAVO, W&H, NSK and Champion Dental low speed motor attachments.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K98 3574
510(k) SUMMARY StarDental® LUBE FREE LOW SPEED MOTOR ATTACHMENTS
Company:
StarDental® . Division of DentalEZ® Owner/operator number 2520265
Contact Person:
William Guscott Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 291-9742
Device Trade Name:
StarDental® TITAN® Series Motor Attachments
Common or Usual Name:
Low Speed Motor Attachments
Predicate Devices:
Star, Midwest, KAVO, W&H, NSK and Champion Dental low speed motor attachments.
Description/Intended Use:
Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.
Substantial Equivalence:
The Low Speed Attachments as submitted are substantially equivalent to other attachments currently being marketed by Star, Midwest, KAVO, W&H, NSK and Champion Dental. Materials used to manufacture the components are similar. Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power to the attachments through a geared drive train for various dental procedures. The differentiation between the predicate devices and the submitted is the redesign of standard lubricated bearings to non-lubricated bearings and bushings.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. The image is black and white.
JAN 8 1999
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Guscott Product Development Engineer StarDental®, Division of DentalEZ® 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re : K983574 StarDental® TITAN® 3 Lubefree Motor Trade Name: Attachments Regulatory Class: I Product Code: EGS Dated: September 29, 1998 Received: October 13, 1998
Dear Mr. Guscott:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Guscott
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamafin.html" .
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Intended Use
Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.
Suan Reaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 108 510(k) Number
Prescription Use
(Per 21 CFR 801.109)