(68 days)
Not Found
No
The summary describes a physical dental abutment system with modifications to its dimensions. There is no mention of software, algorithms, image processing, AI, ML, or performance studies related to such technologies.
No.
The device is described as an abutment used to support a prosthesis in edentulous patients, which is a structural component of a dental implant system, not a device used for treating disease or repairing injury.
No
Explanation: The device is an abutment for dental implants, used to support a prosthesis. Its function is structural and mechanical, not to diagnose a condition or disease.
No
The device description clearly states it is an "abutment used with an endosseous implant," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used in edentulous patients as an anchor to support a prosthesis. This is a mechanical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical abutment used with an implant in the jaw. It describes its physical characteristics and how it connects to the implant. This is consistent with a medical device used for structural support, not for diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended to be used in edentulous patients as an anchor to support a prosthesis.
Product codes
NHA
Device Description
The Nobelpharma Mirus(.one Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw done. The abutment has a lower profile (vertical height) for use when the dentist desires a lower profile abutment. The only modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting the larger and smaller discussion in of fixture previously cleared.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
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Pre-Market Notification May 1, 1996 Page 2
JUL 1 0 1996
510(k) Summary of Safety and Effectiveness VL.
A. Name and Address
This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, II 60559. Their telephone number is (708) 654-9100. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 1, 1996.
B. Name of the Device
This device is known as an abutment to an endosseous implant with the trade name BRANEMARK SYSTEM® MirusCone Abutment System. This submission is a modification to a previously cleared device, K944964.
C. The Predicate Product
The predicate product used in this Premarket Notification is the previous version of the same device, MirusCone Abutment System, K944964.
D. Description of the Device
The Nobelpharma Mirus(.one Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw done. The abutment has a lower profile (vertical height) for use when the dentist desires a lower profile abutment. The only modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting the larger and smaller discussion in of fixture previously cleared.
E. Intended Use of the Device
The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.
F. Comparison of Technological Characteristics
The technological characteristics between the modified version of the MirusCone Abutment and the earlier version are identical. The only changes are minor dimensional changes to the diameters of the abutment, the abutment screw and the prosthetic screw.
1
Image /page/1/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 stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 7 2010
Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA. LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K961728
Trade/Device Name: MirusCone Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2010 Received: July 29, 2010
Dear Ms. Nguyen Son:
This letter corrects our substantially equivalent letter of July 28, 2010.
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 (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.
2
Page 2- Ms. Nguyen Son
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan
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
3
J(k) Number (if known): _ K961728
MirusCone Abutment System Device Name:
Indications For Use:
Intended to be used in edentulous patients as an anchor to support a prosthesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Susan Runner
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K961728
otion Use er =1 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)