(432 days)
Not Found
No
The document describes a physical dental abutment made of PEEK and its intended use and testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
No
Explanation: The device is a prosthetic component for dental implants, intended for provisional use in prosthetic rehabilitation. It aids in the restoration of dental function and aesthetics, rather than directly treating a disease or condition for therapeutic purposes.
No
The device, Nobel Biocare PEEK Abutments, is described as a premanufactured prosthetic component directly connected to endosseous dental implants for provisional use in prosthetic rehabilitation. Its function is to aid in prosthetic rehabilitation, not to diagnose a condition or disease.
No
The device description explicitly states the device is made from PEEK and is a physical component (abutment) for dental implants. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for a structural and functional purpose related to dental implants.
- Device Description: The description further clarifies that they are "endosseous dental implant abutments" made from PEEK. This reinforces their role as a physical component used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting to analyze biological samples.
Therefore, the Nobel Biocare PEEK Abutments are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural color or white. The PEEK Abutments are available in a variety of preformed and customized shapes that can be used either as provisional abutments or as healing abutments. The customized PEEK Abulments must be straight, further design limitations for customized shapes are given in the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endosseous dental implants
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)
Non-clinical testing was performed to support the decision of safety and effectiveness. Non-clinical testing consisted of Biocompatibility testing following ISO 10993. Cytotoxicity testing using the ISO Elution Method (ISO 10993-5) was performed. Also sterilization in accordance with ISO 17665 was performed.
No Clinical test data was used to support the decision of safety and effectiveness.
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.)
0
K120954
1.4 510(k) Summary
5 2013 JUN
| Submitted by: | Phuong Nguyen Son
Requlatory Affairs Manager |
|----------------------------------------|--------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-4800 ext 7830 |
| Facsimile: | (714) 998-9348 |
| Date Prepared: | 4 June, 2013 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Product Code: | NHA |
| Trade or Proprietary
or Model Name: | NobelProcera PEEK Abutments |
| Legally Marketed Device(s): | Brånemark System Temporary Solutions (K925766)
Neo Implant System (K043195) |
Device Description:
NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural color or white. The PEEK Abutments are available in a variety of preformed and customized shapes that can be used either as provisional abutments or as healing abutments. The customized PEEK Abutments can be shaped to follow the contour of the tissue intended to surround the definitive abutment. Customized PEEK Abulments must be straight, further design limitations for customized shapes are given in the Instructions for Use.
Indications for Use:
The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Non-Clinical Testing:
Non-clinical testing was performed to support the decision of safety and effectiveness. Non-clinical testing consisted of Biocompatibility testing following ISO 10993. Cytotoxicity testing using the ISO Elution Method (ISO 10993-5) was performed. Also sterilization in accordance with ISO 17665 was performed.
Clinical Testing:
No Clinical test data was used to support the decision of safety and effectiveness.
Conclusions:
The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device.
Nobel Biocare 510(k) Notification NobelProcera PEEK Abutments March 2012
1
510(k) Summar 1.4
Substantial Equivalence Comparison to Predicate Device
| CHARACTERISTIC | CANDIDATE
NobelProcera PEEK Abutments | PREDICATE
Brånemark System Temporary
Solutions
(K925766) | PREDICATE
Neo Implant System*
(K043195) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |
| Color | Natural & White | Natural | White |
| Attachment Method | Screw retained
Engaging & Non Engaging | Screw retained
Engaging & Non Engaging | Screw retained |
| Intended Use | Healing abutment
Provisional abutment | Provisional abutment | Healing abutment
Provisional abutment |
| Duration of Use | 180 days | 90 days | 180 days |
| Implant/Abutment
Connection | Nobel Biocare
- External Hex
- Internal Conical
- Internal Tri-lobe | Nobel Biocare
- External Hex
- Internal Conical
- Internal Tri-lobe | Neoss
- Internal Hex |
| Abutment Profile | Provisional abutments - Straight walled
or designed with Procera system - Healing Abutments - Various
anatomical shapes intended for
different tooth locations or individually
designed with Procera system | Straight walled | Provisional abutments - Straight walled - Healing Abutments - Various
anatomical shapes intended for different
tooth locations |
This predicate contains a full implant system including provisional and anatomical healing abutments made of PEEK. This 510(k) is only using these
abutments as a predicate
.
:
Nobel Biocare Traditional 510(k) Notification
NobelProcera PEEK Abutments
March 2012
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2013
Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, Limited Liability Company 22715 Savi Ranch Parkway YORBA LINDA CA 92887
Re: K120954
Trade/Device Name: NobelProcera PEEK Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 20, 2013 Received: May 21, 2013
Dear Ms. Son:
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,-1.976, 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.
3
Page 2 - Mr. 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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours,
Susan Runner DESIGNS Mary S. Runner
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K120954 510(k) Number (if known):
Device Name: NobelProcera PEEK Abutments
Indications For Use:
The Nobel Blocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental Implants and are intended for provisional use up to 180 days 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)
Andrew I. Steen 2013.06.05 08:44:23 04'00'
Page 1 of 1
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: