(104 days)
This Device is to be used by a Dental Hygienist for cleaning procedures on teeth. For the coupling of Disposable Prophy Angles to Dental Handpiece motors.
Prescription Use: Used by dental Professional Only
Over the Counter Use: No
DPA Attachment Twist/Flex Adapter
I am sorry but this document is a 510(k) clearance letter from the FDA for a dental device (DPA Attachment Twist/Flex Adapter). It primarily addresses the regulatory approval process and includes an "Indications for Use" statement.
I am unable to find the requested information in the document provided, in particular there is no mention of:
- Acceptance criteria or device performance results.
- Details on sample sizes, data provenance, or ground truth establishment for any studies.
- Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
- An effect size of how much human readers improve with AI vs without AI assistance.
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Image /page/0/Picture/0 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" arranged around the perimeter. Inside the seal is a stylized emblem featuring three abstract shapes resembling human figures or flowing lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Chris Carron President Angstrom Manufacturing, Incorporated 6539 U.S. Highway 61 Bloomsdale. Missouri 63627
FEB - 7 201
Re: K103158
Trade/Device Name: DPA Attachment Twist/Flex Adapter Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: January 31, 2011 Received: February 2, 2011
Dear Mr. Carron:
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. 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- Mr. Carron
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 (OS) 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/ucm11.5809.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 vours,
Susan Turner
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
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Image /page/2/Picture/0 description: The image shows the logo for "ANGSTROM MANUFACTURING, INC.". The logo features a stylized "A" inside a square on the left. The words "ANGSTROM" are in large, bold, sans-serif font, and the words "MANUFACTURING, INC." are in a smaller font below the word "ANGSTROM".
4 Indications for Use Statement 014-10-1004_ Indications for Use - Twist-Flex Adapter.docx Page 1 of 1
September 1, 2010
Indication for Use - DPA Attachment Twist/Flex Adapter Project's 001,002,014,015,016,017,018,019
510(k) Number: K103158
Device Name: DPA Attachment Twist/Flex Adapter
Indication:
This Device is to be used by a Dental Hygienist for cleaning procedures on teeth. For the coupling of Disposable Prophy Angles to Dental Handpiece motors.
Prescription Use: Used by dental Professional Only Over the Counter Use: No
Susan Russe
Division Sign-Off) Division Sign-Off)
Division of Anesthesiology, General Hospital
Clivision of Anesthesiology, General Devices Division of Anastison of Anastial Devices
Infection Contro
510(k) Number. K103138
Angstrom Manufacturing, Inc. ■ 6539 US Hwy 61 · Bloomsdale MO 63627 Ph: 573-483-3773 ■ Fax: 573-483-2462 ■ E-Mail: chriscarron@angstrom-mfg.com
§ 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.