(126 days)
No
The 510(k) summary describes a mechanical dental handpiece with no mention of software, algorithms, or any technology related to AI or ML. The changes described are purely mechanical improvements.
No
A dental handpiece is used for mechanical procedures like drilling or polishing, not for treating a disease or condition itself.
No
The device is described as an air-powered dental handpiece used for general dentistry. Its description focuses on mechanical improvements and safety features related to bur retention and usability, not on identifying medical conditions or diseases.
No
The device description clearly describes a physical dental handpiece with mechanical components (autochuck mechanism, spring, body shell) and physical characteristics (weight, knurling). It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an air-powered dental handpiece for use by a trained professional in general dentistry." This describes a tool used directly on a patient for dental procedures, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the mechanical aspects of the handpiece (air-powered, autochuck mechanism, weight, knurling) and its function in a dental setting. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status based on laboratory tests
Therefore, this device is a medical device used for treatment and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
Product codes
EFB
Device Description
The Vector F series handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. The only major design or engineering change is the strength of the autochuck mechanism. By increasing the spring strength we have created and even safer version of the KaVo 625CD. By increasing the bur retention strength form 6 lbs (as with the predicate device) to 8 lbs (Vector F series) we have been able to vastly reduce the odds of a bur prematurely ejecting for the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece even safer are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softened the knurling on the handle. This allows dirt, blood and saliva to be more easily removed from the body shell of the handpiece thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.
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 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
MAY 1 7 2002
EXHIBIT 2 Vector Research & Development 1909 70th Ave W, #C University Place, WA 98466 Tel (253) 564-5084 Fax (253) 564-4927 December 13, 2001 Contact: Brent Bigler
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: "Vector F Series" High-speed Dental Handpieces. Classification Name: EFB Common/Usual Name: HANDPIECE, AIR-POWERED, DENTAL
-
- Indications for Use (intended use) The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
-
- Description of the Device: The Vector F series handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. The only major design or engineering change is the strength of the autochuck mechanism. By increasing the spring strength we have created and even safer version of the KaVo 625CD. By increasing the bur retention strength form 6 lbs (as with the predicate device) to 8 lbs (Vector F series) we have been able to vastly reduce the odds of a bur prematurely ejecting for the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece even safer are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softened the knurling on the handle. This allows dirt, blood and saliva to be more easily removed from the body shell of the handpiece thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.
1
| Element of Comparison | StarDental 430 Series,
K982593; KaVO 625/634
Handpieces, K760929 | Vector F Series |
|-----------------------|------------------------------------------------------------------------|-------------------------|
| Intended Use | General dentistry by trained professional. | SAME |
| Materials: | Handpiece housing | Copper-tin Bronze |
| | Turbine Housing | Nickel silver CDA alloy |
| | Turbine housing cap | Stainless steel |
| | Plating | Chrome |
| Energy source | Air pressure, 30-32 psi | SAME, 30-35 psi |
| Sterilization | Steam autoclave or chemical vapor | SAME |
-
- Safety and Effectiveness, comparison to predicate device:
-
- Conclusion: In all respects, the Vector F Series High-speed Dental Handpieces are substantially equivalent to one or more air-powered dental handpieces currently marketed in the USA. The handpieces are constructed of identical materials and marketed in and Obstandards. The ability to repeatedly sterilize the devices has been confirmed through performance of a validation protocol.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2002
Vector Research & Development C/O Mr. Daniel Kamm Kamm & Associates P. O. Box 7007 Deerfield, Illinois 60015
Re: K020113
Trade/Device Name: Vector F Series High-Speed Dental Handpieces Regulation Number: 872.4200 Regulation Name: Dental Handpiece Regulatory Class: I Product Code: EBF Dated: March 25, 2002 Received: March 26, 2002
Dear Mr. Kamm:
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.
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.
3
Page 2 - Mr. Kamm
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cucciniello
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO20113
j) Indications for Use
510(k) Number
Device Name: "Vector F Series" High-speed Dental Handpieces.
Indications for Use: The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use OR Prescription Use V (Per 21 CFR 801.109) seen (Division Sign-Off)
Division of Dental, (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Deviceുപ്പുഴ (Division of Dental, Innection)
and General Hospital Devices (000) and GeNember –