(185 days)
Not Found
No
The description focuses on the mechanical function of a dental handpiece and does not mention any AI or ML components or capabilities.
No.
The device description indicates its primary function is for mechanical dental procedures like removing carious material, preparing cavities, and polishing teeth, which are restorative or preparatory actions rather than therapeutic in the sense of treating or curing a disease or disorder through non-mechanical means.
No
The device is described as a dental handpiece used for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations, and polishing teeth. These are all therapeutic or interventional actions, not diagnostic ones.
No
The device description clearly details a physical dental handpiece with mechanical components (turbine, impeller, spindle, air and water tubes) 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 describes a device used in the practice of dentistry for procedures performed directly on the patient's teeth. This involves physical interaction with the patient's body.
- Device Description: The description details a mechanical device that uses air and water to rotate a cutting bur for dental procedures. This is a tool used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
This Handpiece is used by authorized persons in the practice of dentistry.
This Handpiece is intended for removing carious material, reducing hard tooth structures, cavity preparations, finishing tooth preparations, restorations and polishing teeth.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.
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 sharik (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)
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 a handwritten string of characters. The characters appear to be "K080682". The writing is in black ink on a white background. The characters are somewhat stylized and connected.
Image /page/0/Picture/1 description: The image shows the logo for "Handpiece Headquarters". The text is in a bold, sans-serif font, with the word "Handpiece" stacked on top of the word "Headquarters". There is a line below the text, and some other text below the line, but it is too small to read. The logo is black and white.
510(K) SUMMARY:
SEP 1 1 2008
AIR-POWERED HANDPIECE MODELS: HENRY SCHEIN/ HHC/ SCORE Canister Handpiece. (Identical Handpiece/ 3 difference labels) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
| 510K | |
|---|---|
| a- Submitted by: | HANDPIECE HEADQUARTERS |
| 2284 N. GLASSELL ST. UNIT A. ORANGE, CA.92865 | |
| Tel. 714-685-3070 Fax. 714-921-1852 | |
| b- Contact person: | Tina Steffanie-Oak |
| Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240 | |
| Email: tina.steffanie-oak@henryschein.com | |
| c- Date summary prepared: | 03/06/08 |
| d- Device Name: | |
| Trade or Proprietary Name: | HENRY SCHEIN Canister Handpiece |
| Common Name: | Air-Power Dental Handpiece |
| Classification Name: | 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: | |
| SUPER-AIR S: Standard, 400,000 rpm, Wrench Type Chuck | |
| SUPER-AIR: Standard, 400,000 rpm, push button chuck. | |
| Products of Peng Lim Enterprise Co., Ltd. (K062947) | |
| f- Description of the device: |
f- Description of the device:
The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.
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 sharik (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 Handpiece is used by authorized persons in the practice of dentistry.
This Handpiece is intended for removing carious material, reducing hard tooth structures, cavity preparations, finishing tooth preparations, restorations and polishing teeth.
h- Safety and effectiveness of the device:
The canister handpiece is as safe and effective as the predicate device as cited above.
I – Conclusion:
Based on the information in the notification Handpiece Headquarters believes that this Canister Handpiece is substantially equivalent to the claimed predicate device. ( SUPER-AIR S & SUPER-AIR U Handpiece Models manufacture by PENG LIM ENTERPRISE CO., Ltd.)
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
SEP 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina Steffanie-Oak Senior Regulatory Specialist Handpiece Headquaters Incorporated 2284 North Glassell Street, Unit A Orange, California 92856
Re: K080682
Trade/Device Name: Henry Schein Canister Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Codc: EFB Dated: September 9, 2008 Received: September 10, 2008
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 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.
3
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); 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.
V.H. Arnold's Penders. foell
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
4
Indications for Use
... ... ... ... ... ... ... ... ... ... ... ... ... .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Number (if known): K080682
Device Name: Henry Schein Canister Handpiece
Indications for Use:
The Dental Handpiece is used by authorized persons in the practice of dentistry.
This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
AND/OR Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
Over-The-Counter Use
(Per 21 CFR 801 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
Susan Pearson
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080682