(177 days)
Not Found
No
The document describes a mechanical dental handpiece turbine replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a replacement part for a dental handpiece, which is used for mechanical procedures like removing carious material and polishing teeth. It does not directly treat or prevent a disease, nor does it affect the structure or function of the body in a therapeutic manner.
No
Explanation: The device is a replacement turbine for a dental handpiece used for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations, and polishing teeth. These are all treatment or preparation procedures and do not involve diagnosing a condition.
No
The device description clearly describes a physical air turbine with mechanical components (impeller, spindle, air intake tube, water inlet tube) and does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a replacement turbine for a dental handpiece used for procedures like removing carious material, cavity preparations, and polishing teeth. These are all procedures performed directly on the patient's teeth.
- Device Description: The description details how the turbine works mechanically to rotate a dental bur for cutting and polishing. It also mentions cooling water, which is applied to the cutting area on the tooth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is an accessory for a dental handpiece used in vivo (inside the body, specifically in the mouth) for mechanical procedures.
N/A
Intended Use / Indications for Use
This HHC-Push button air turbine is intended to use with Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.
The Midwest Tradition Handpiece with the replacement turbine is used by authorized persons in the practice of dentistry.
The replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
Product codes
EFB
Device Description
The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.
High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.
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
authorized persons in the practice of 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)
The HHC-Push button air turbine performance tests were carried out to evaluate it against the predicate device. In all instances the HHC-Push button air turbine functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate. No clinical data was required.
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
§ 872.4200 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
Handpiece
Headquarters
AUG 2 2010
34
A HENRY SCHEIN® COMPANY
510(K) SUMMARY:
HHC- push button replacement turbine for Midwest Tradition.
210K
a- Submitted by:
HANDPIECE HEADQUARTERS 620 S. Placentia Ave. Placentia, CA 92870 Tel. 714-579-0175 Fax. 714-579-0186
b- Contact person: ·
Tina Steffanie-Oak Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240 tina.steffanie-oak@henryschein.com Email:
c- Date summary prepared:
Revised 06-10-10
d- Device Name:
HHC- push button replacement turbine for Midwest Tradition Trade or Proprietary Name:
Common Name: Classification Name: Air-Power Dental Handpiece Dental Handpiece and accessories (21CFR 872.4200) Class: I
Product Code:
EFB "Handpiece, Air-powered, Dental"
e- Substantial Equivalency is claimed against the following device:
NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK NAKANISHI INC. (K971774)
f- Description of the device:
The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.
High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle),
1
which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.
g- Statement of Intended Use:
This HHC-Push button air turbine is intended to use with Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.
The Midwest Tradition Handpiece with the replacement turbine is used by authorized persons in the practice of dentistry.
The replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
h- Safety and effectiveness of the device:
The HHC-Push button air turbine is as safe and effective as the predicate device as cited above.
1 - Device and Predicate Comparison Table:
| Descriptive Information | Subject Device: HHC-Midwest
Tradition Replacement Turbine | Predicate: NSK-Midwest Tradition
Replacement Turbine |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication of use | This HHC-Push button air turbine is
intended to use in Midwest Tradition
Handpiece in replacement of Midwest
Tradition's original turbine.
The Dental Handpiece with the
replacement turbine is used by
authorized persons in the practice of
dentistry.
This replacement turbine used in
Midwest Tradition Handpiece is
intended for removing carious material,
cavity preparations, finishing tooth
preparations, reducing hard tooth
structures, restorations and polishing
teeth: | The devices claimed herein are the air turbines
only, not the handpiece itself.
The devices are intended for use in the
Midwest's Quiet-air or Tradition handpieces, in
place of Midwest's original turbines.
The device, therefore, is, with Midwest
handpiece, intended for use in general dental
applications, such as cutting a tooth for crown
preparation, cavity preparation, finishing the
crown, inlay or the filling, etc. |
| Device Design: | | |
| Operation mode | Intake air pressure 35 psi- speed
420,000 rpm. Min. | Intake air pressure 35 psi- speed 420,000 rpm
Min. |
| Air/water ports | N/A | N/A |
| Fiber Optics | N/A | N/A |
| Type of chuck | Push button chuck (auto chuck) | Push button chuck(auto chuck) |
2
| Coupling dimensions | n/a | n/a |
|---|---|---|
| Accessories | n/a | n/a |
| Composition of material | ||
| Spindle | 440C stainless steel (see more details in attachment 4 material table) | Stainless steel |
| Impeller | Aluminum (see more details in attachment 4 material table) | Aluminum |
| Bearings | 440C stainless steel. (see more details in attachment 4 material table) | Stainless steel |
| O-ring | Buna (see more details in attachment 4 material table) | Buna |
| Technical specification | ||
| Chuck | Push button chuck spindle | |
| Outside diameter: 0.125" | ||
| Chuck length: 0.425" | ||
| Actuator height: 0.034" | Push Button: | |
| Outside diameter: 0.125" | ||
| Chuck length: 0.435" | ||
| Actuator height: 0.038" | ||
| Light intensity | n/a | n/a |
| Bur extraction force | 5 lbs Min. push and pull forces/ 100 inspection using ONMI gauge/ per specification indicated on drawing | 5 lbs Min. push and pull forces- tested on predicate device |
| Air pressure | 35 psi. recommended | 35 psi. |
| Water pressure | 2 bar | 2 bar |
| Speed Rpm | 420,000 rpm. Min. | 420,000 rpm. Min. |
| Hose connection | n/a | n/a |
| Conformance standard for shanks | Meet I.S.O standard Shank diameter from 0.0625" to 0.0630" | Meet I.S.O standard shank |
| Lubricant | n/a | Dental lubricated oil |
| Lubricant recommended but specific type and it is not indicated in labeling. |
J - Performance Data:
The HHC-Push button air turbine performance tests were carried out to evaluate it In all instances the HHC-Push button air turbine against the predicate device. functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate.
No clinical data was required.
K -Conclusion:
Based on the information in the notification Handpiece Headquarters believes that this HHC-Push button air turbine is substantially equivalent to the claimed predicate device. (NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK-NAKANISHI INC. (K971774))
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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 lines representing its wings and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tina Steffanie-Oak Senior Regulatory Specialist Handpiece Headquarters 620 S. Placentia Avenue Placentia, California 92870
AUG 1, 2 2010
Re: K100389
Trade/Device Name: HHC- push button replacement turbine for Midwest Tradition Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: II Product Code: EFB Dated: August 6, 2010 Received: August 6, 2010
Dear Ms. Steffanie-Oak:
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 preemarket approval application (PMA). You may, therefore, market the device, subject to the emeral 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.
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Page 2 - Ms. Steffanie-Oak
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. 10, 10, 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Wh 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
5
Indications for Use
AUG 1 2 2010
510(k) Number (if known): Kloo389
Device Name: HHC- push button replacement turbine for Midwest Tradition
Indications for Use:
This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.
The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry.
The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
Prescription Use .X AND/OR (Per 21 CFR 801 Subpart D) Subpart C)
Over-The-Counter Use
(Per 21 CFR 801
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Loe Miley for MSP Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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