(118 days)
BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment.
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This appears to be a 510(k) premarket notification for a dental abutment, which is a mechanical component, not a device that processes or analyzes data. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of software or AI/ML performance are not directly applicable in the way you've framed them for a data-driven device.
The information provided describes the regulatory submission for a physical medical device (Low Profile Abutment). The "acceptance criteria" for a physical device like this typically pertain to engineering specifications, material properties, biocompatibility, mechanical strength, and manufacturing quality, often demonstrated through laboratory testing, simulations, and adherence to recognized standards.
Here's why your specific questions about AI/ML performance, sample sizes for test/training sets, expert adjudication, and MRMC studies don't apply to this document:
- No AI/ML Component: The submission focuses on the mechanical function of a dental abutment (supporting a prosthetic device). There's no mention of any software, AI, or machine learning algorithms involved in its function or its regulatory review.
- Physical Device, Not Data-Driven: The "device" in question is a physical object implanted in a patient's mouth. Its performance is assessed through its physical properties and how it interacts with other physical components (implants, prostheses), not through data analysis or diagnostic interpretation.
- Regulatory Pathway: The document identifies this as a "Traditional 510(k) Pre-market Notification." This pathway assesses substantial equivalence to a predicate device, primarily focusing on similar technological characteristics and indications for use, often supported by design specifications, material testing, and sometimes bench or animal testing, rather than clinical studies of diagnostic accuracy.
Therefore, I cannot extract the requested information from the provided text because it describes a physical medical device submission, not an AI/ML-powered or data-driven device.
If you have a document related to an AI/ML or software device, I would be happy to analyze it against your criteria.
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Traditional 510(k) Pre-market Notification - Low Profile Abutment
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510(k) Summary
NOV 3 0 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
1038806
July 27th, 2009
Delivery Device
Submitter:
Biomet 3i
BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410
Establishment Registration Number: Contact:
Jose E. Cabrera Sr. Manager, Regulatory Affairs BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 Tel. 561-776-6923 Fax. 561-514 6316 Email jose.cabrera@biomet.com
Trade/Proprietary Name: N/A
Common/Usual Name: Low Profile Abutment
Abutment, implant, dental, endosseous Classification Name:
Class II - 21 CFR $872.3630 / NHA Device Classification/Code:
Predicate Device:
Date Prepared:
Indications for Use:
BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment.
Conical Abutments (Straight and Angled), Immediate
Occlusal Loading (IOL) Abutments, Asyst Abutment
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Jose E. Cabrera Senior Medical, Regulatory Affairs Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
NOV 3 0 2009
Re: K092341
Trade/Device Name: Low Profile Abutment Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 17, 2009 Received: November 18, 2009
Dear Mr. Cabrera:
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.
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Page 2- Mr. Cabrera
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. 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.
N for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Low Profile Abutment
Indications for Use:
BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Br. Kerin Thur D850
(Division Sign-Qui (Division of Anesthesiology, General Hospital Infection Control. Dental Devices
- 510(k) Number: K09234
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)