(82 days)
No
The summary describes a premanufactured prosthetic component and its fabrication process, with no mention of AI or ML technologies.
No
Explanation: The device is a prosthetic component (abutment) used in dental rehabilitation, not designed to treat or cure a disease or condition.
No
The device is a premanufactured prosthetic component (a zirconia abutment for dental implants) intended for aid in prosthetic rehabilitation, not for diagnosing conditions. Its description focuses on its design, fit, and function as a prosthetic component.
No
The device description explicitly states it is a "premanufactured prosthetic component" and is "fabricated to the exact shape, size, and specifications determined in the design process," indicating it is a physical hardware device (a dental abutment).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation" and describes a premanufactured prosthetic component that fits into dental implants. This is a mechanical/structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics and function of the abutment as a personalized device for fitting and functioning within a patient's mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Nobel Biocare's Procera Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants:
– Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
Product codes
NHA
Device Description
Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.
Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is similar in design, intended use, and operation to the abutments cleared in predicate devices.
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
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 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
K06 1529
1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Phuong Nguyen Son
Regulatory Affairs Specialist | AUG 23 2006 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 | |
| Telephone: | (714) 282-4800, ext. 7830 | |
| Facsimile: | (714) 282-9023 | |
| Date of Submission: | June 1, 2006 | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Trade or Proprietary
or Model Name: | Procera Titanium Abutment for Camlog Implant System | |
| Legally Marketed Device(s): | Procera Abutment Octagon (K041275)
Procera Abutment Brånemark (K042658)
Altatec Camlog Screwline Implant System (K022425) | |
Device Description:
Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.
Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is similar in design, intended use, and operation to the abutments cleared in predicate devices.
Indications for Use:
Nobel Biocare's Procera Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants:
| Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2006
Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K061529
Trade/Device Name: Procera Zirconia Abutment for Camlog Implant System Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 1, 2006 Received: June 12, 2006
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, 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 such 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. Son
ﺎﻧ
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suette y. Michael Davis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K061539 510(k) Number (if known):
Device Name: Procera Zirconia Abutment for Camlog Implant System
Indications For Use:
Nobel Biocare's Procera Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants:
– Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
× 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)
Susan Runne
on of Anesthesiology, General Hospital, con Control, Dental Devices
Page 1 of _1 _________________________________________________________________________________________________________________________________________________________________
- Number: K061529
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