(113 days)
Not Found
No
The summary describes a physical dental prosthesis (bridge laminate) and its material and manufacturing process (milling from zirconium oxide). There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No.
This device is a prosthetic component (bridge laminate) intended to replace a missing tooth, not to treat or cure a disease or condition. It serves as a structural component for a restoration.
No
This device is a prosthetic bridge used to replace a missing tooth and does not perform any diagnostic function.
No
The device description clearly states the device is a physical structure (bridge laminate) made of zirconium oxide and porcelain, which is then cemented or bonded to natural teeth. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nobel Biocare Procera® Bridge Laminate is a physical prosthesis designed to replace a missing tooth. It is a structural component that is bonded onto natural teeth.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device is a manufactured product used for restorative purposes.
Therefore, the device falls under the category of a dental prosthesis or restorative device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Nobel Biocare's Procera® Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Nobel Biocare's Procera® Bridge Laminate serves as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region.
The Procera® Laminate Bridge is two thin lingual laminates and a pontic precision milled from one solid piece of zirconium oxide (Zirconia), which is then veneered with porcelain. After the bridge is veneered by the dental laboratory and sent to the clinician, the completed bridge is cemented or bonded to natural teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
missing tooth between surrounding remaining teeth in the esthetic region
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
1.4 510(k) Summary of Safety and Effectiveness
| 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 31, 2005 |
| Classification Name: | Porcelain Tooth (21 CFR 872.3920) |
| Trade or Proprietary
or Model Name: | Procera® Bridge Laminate |
| Legally Marketed Device(s): | Procera® Copings & Pontic (K032562) |
Device Description:
Nobel Biocare's Procera® Bridge Laminate serves as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region.
The Procera® Laminate Bridge is two thin lingual laminates and a pontic precision milled from one solid piece of zirconium oxide (Zirconia), which is then veneered with porcelain. After the bridge is veneered by the dental laboratory and sent to the clinician, the completed bridge is cemented or bonded to natural teeth.
Indications for Use:
Nobel Biocare's Procera® Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.
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 lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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: K053068
Trade/Device Name: Procera Bridge Laminate, Model 40-4002 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 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, FIDA may publish further announcements concerning your device in the Federal Register.
2
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 moun that 1 DT may may Federal statutes and regulations administered by other Federal agencies. or not 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 and if the (- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirements as betrenir 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) ring letter notification. The FDA finding of substantial equivalence of your device to a premaired tourseand 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), 11 you dontact 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 maj South 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.
Sincercly yours,
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
Indications for Use
K053068 510(k) Number (if known):
Device Name: Procera Bridge Laminate
Indications For Use:
Nobel Biocare's Procera Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.
× 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)
Sura Quares
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