(117 days)
No
The summary describes a prefabricated, precision-milled dental bridge made of alumina, with no mention of AI or ML in its design, manufacturing process, or intended use.
Yes
The device is used as a prosthesis to restore chewing function in partially edentulous patients, which is a therapeutic goal.
No
The device is described as a prefabricated core structure for an artificial prosthesis to restore chewing function, not to diagnose a condition.
No
The device description clearly states it is a prefabricated device manufactured from a solid piece of aluminum oxide, indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description and Intended Use: The description and intended use of the Nobel Biocare Procera Bridge Alumina clearly state that it is a prosthetic device intended for placement in the oral cavity to restore chewing function. It is a physical structure, not a tool for analyzing biological samples.
The device is a dental prosthesis, not a diagnostic test.
N/A
Intended Use / Indications for Use
Nobel Biocare's Procera® Bridge Alumina is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.
Product codes
NHA
Device Description
Nobel Biocare's Procera® Bridge Alumina is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.
The Procera® Bridge Alumina may be two, three, or four units and is precision milled. The Procera Bridge Alumina can be cemented or bonded to either natural or artificial tooth abutments. It is personalized according to the specific dimensions of the patient's so the bridge precisely fits, and properly functions, in the patient's jaw.
Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Procera® Bridge Zirconia (K041283)
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
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K053050'. The characters are written in a bold, somewhat irregular style, giving them a distinct, hand-drawn appearance. The contrast between the characters and the background is high, making the sequence easily readable.
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Phuong Nguyen Son
Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| 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: | October 26, 2005 |
| Classification Name: | Porcelain Tooth (21 CFR 872.3920) |
| Trade or Proprietary
or Model Name: | Procera® Bridge Alumina |
| Legally Marketed Device(s): | Procera® Bridge Zirconia (K041283) |
Device Description:
Nobel Biocare's Procera® Bridge Alumina is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.
The Procera® Bridge Alumina may be two, three, or four units and is precision milled. The Procera Bridge Alumina can be cemented or bonded to either natural or artificial tooth abutments. It is personalized according to the specific dimensions of the patient's so the bridge precisely fits, and properly functions, in the patient's jaw.
Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).
Indications for Use:
Nobel Biocare's Procera® Bridge Alumina is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2006
Nobel Biocare USA AB C/O Mr. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K053050
Trade/Device Name: Procera Bridge Alumina Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 10, 2006 Received: February 13, 2006
Dear Mr. 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include econorements 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 Eederal Register.
2
Page 2 - Mr. Son
Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast be advisod that 127 to testainst on that your device complies with other requirements modi that I Dri nas made waters and regulations administered by other Federal agencies. of the Act of any I outeral based is requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR rat 807), availity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ijon 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) This letter will and in J . The FDA finding of substantial equivalence of your device to a premarket notification. The PDF 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), If you desire specific at the not no no no at (240) 276-0115. Also, please note the regulation prease contact the Online reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih-Lin, Ph.D.
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
KOS3050 510(k) Number (if known):
Device Name: Procera Bridge Alumina
Indications For Use:
Nobel Biocare's Procera Bridge Alumina is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.
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)
Susa Quaser
technology, General Hosp.
and Dental Devices
K05 3050