(92 days)
No
The summary describes a premanufactured dental abutment and does not mention any AI or ML components or functionalities.
No
The device is a prosthetic component that aids in rehabilitation, but it does not treat or cure a disease or condition; it provides a platform for restoration.
No
The device description indicates it is a premanufactured prosthetic component and provides a platform for restoration, not for diagnosing medical conditions. Its intended use is an aid in prosthetic rehabilitation.
No
The device description clearly states that the NobelProcera Zi Abutments are physical components made of zirconium oxide, which are attached to dental implants. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces this by stating it's an "endosseous dental implant abutment" that "attaches directly to endosseous dental implants and provides a platform for restoration." This is a physical component for dental procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the NobelProcera Zi Abutments are a medical device used in dental surgery and prosthetics, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NobelProcera Zi Abulments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
Nobel Biocare's NobelProcera Zi Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Zi Abutment attaches directly to endosseous dental implants and provides a platform for restoration.
Nobel Biccare's NobelProcera ZI Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.
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
Prescription Use
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.)
0
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Herbert Crane, Director Global Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC |
| 22715 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Telephone: | (714) 282-4800, ext. 5074 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | June 24, 2009 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary | |
| or Model Name: | NobelProcera Zi Abutment |
| Legally Marketed Devices: | Nobel Biocare - Procera ® Abutment Brånemark (K042658) |
| Nobel Biocare - Procera® Implant Bridge Overdenture (K090064) | |
| SEP 2 5 2009 |
Device Description:
Nobel Biocare's NobelProcera Zi Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Zi Abutment attaches directly to endosseous dental implants and provides a platform for restoration.
Nobel Biccare's NobelProcera ZI Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.
Indications for Use:
The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
000018
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K091904
Trade/Device Name: NobelProcera Zi Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 11, 2009 Received: September 14, 2009
Dear Mr. Crane:
This letter corrects our substantially equivalent letter of September 25, 2009.
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.
SEP 9 2010
2
Page 2 - Mr. Crane
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.html 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.
for
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
Indications for Use
. 510(k) Number (if known):
Device Name: NobelProcera Zi Abutment
Indications For Use:
The NobelProcera Zi Abulments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rian Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of _1
510(k) Number: K091904