(44 days)
Not Found
No
The 510(k) summary describes a mechanical dental handpiece attachment and sheath, with no mention of AI, ML, image processing, or any other computational or data-driven features.
No
The device is described as an attachment for a dental handpiece used for procedures like removing carious material and polishing teeth, which are restorative and preparative dental actions, not therapeutic in the sense of treating a disease or disorder.
No
The provided text describes the device's function as removing carious material, preparing cavities and crowns, finishing tooth preparations, reducing hard tooth structures, restorations, and polishing teeth, which are all treatment and modification procedures, not diagnostic ones.
No
The device description clearly states it is a physical attachment (Straight Attachment and Contra Angle Sheath) used with a dental handpiece, indicating it is a hardware device.
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 for mechanical procedures on teeth (removing material, preparing cavities, polishing, etc.). This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description confirms it's an attachment for a dental handpiece, facilitating mechanical work.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.
Product codes
EGS
Device Description
The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)
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)
MIDWEST STRAIGHT ATTACHMENT-K792445, NSK CONTRA ANGLE SHEATH-K962540
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
Image /page/0/Picture/1 description: The image contains the words "Handpiece Headquarters" in a stylized font. The word "Handpiece" is stacked on top of the word "Headquarters". Above the word "Handpiece" is a line that looks like an EKG reading. The text is in black and the background is white.
IG 20 2009
Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath 510(K) SUMMARY: 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 Email: tina.steffanie-oak@henryschein.com c- Date summary prepared: 06/26/09 d- Device Name; Trade or Proprietary Name: Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath Common Name: Straight Attachment & Contra Angle Sheath Classification Name: Handpiece Contra-And Right-Angle Attachment, Dental (21CFR 872.4200), Class 1, Product Code EGS e- Substantial Equivalency is claimed against the following devices:
MIDWEST STRAIGHT ATTACHMENT-K792445 NSK CONTRA ANGLE SHEATH-K962540
- f- Description of the device: The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)
g- Statement of Intended Use:
The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crow preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.
h- Safety and effectiveness of the device:
The Straight Attachment & Contra Angle Sheath are as safe and effective as the predicate devices as cited above.
1
l -- Conclusion:
Based on the information provided in this submission Handpiece Headquarters believes that the Straight Attachment & Contra Angle Sheath are substantially equivalent to the predicate devices identified.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tim Ropchan General Manager Handpiece Headquarters 620 South Placentia Avenue Placentia, California 92870
Re: K092053
Trade/Device Name: Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath for use with Low Speed Handpiece
Regulation Number: 872.4200
Regulation Name: Dental Handpiece and Accessories
Regulatory Class: I
Product Code: EGS
Dated: June 25, 2009
Received: July 7, 2009
Dear Mr. Ropchan:
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 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- Mr. Ropchan
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/CDRH ffices/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,
Susan Runov
Susan Runner, D.D.S., M.A. Acting 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):
Device Name: Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath for use with a Low Speed Handpiece
Indications for Use:
The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
These attachments are used by authorized persons in the practice of dentistry.
Prescription Use × (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
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)
Robert Betz DDS for Dr. Kevin Mulry
(Division Sign Off)
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092053