(14 days)
No
The document describes a physical dental implant bridge framework and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a bridge framework used to restore chewing function, which is a prosthetic and restorative purpose, not a therapeutic one.
No
The device is described as a bridge framework for restoring chewing function in edentulous jaws, not for diagnosing medical conditions.
No
The device description explicitly states the device is a "bridge framework" made entirely of titanium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore chewing function in partially or totally edentulous jaws by serving as a bridge framework attached to implants. This is a restorative dental device used directly in the patient's mouth.
- Device Description: The description details a physical bridge framework made of titanium, designed to be finished with dental materials and attached to implants. This is a physical implantable or prosthetic device.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural component for dental restoration.
N/A
Intended Use / Indications for Use
The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring function [K043042]. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
- 318 3.75 -
- Lifecore® Biomedical Restore 3,75 -
- Zimmer® Dental Taper-lock 4.0 .
- Sterngold Implamed® 3.75 -
[K043042] The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
• 3i® 3.75
- Lifecore® Biomedical Restore 3.75
· Zimmer® Dental Taper-lock 4.0
· Sterngold Implamed® 3.75
Product codes
NHA
Device Description
Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridges are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium.
The Procera® Implant Bridge implant interfaces are modeled after similar interfaces currently available for the predicate devices listed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Jaws (edentulous)
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)
K041236, K032263, K954512, K011038, K981516
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
(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Elizabeth J. Mason, Sr. 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: | November 3, 2004 |
| Classification Name: | Endosseous Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary | |
| or Model Name: | Procera® Implant Bridge |
| Legally Marketed Devices: Procera® Implant Bridge (K041236) | |
| 3i Dental Abutment (K032263) | |
| Restore Self-Tapping Dental Implant System (K954512) | |
| Taper-lock Dental Implant System (K011038) | |
| Sterngold ImplaMed Hex Implant (K981516) |
Device Description:
Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridges are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium.
The Procera® Implant Bridge implant interfaces are modeled after similar interfaces currently available for the predicate devices listed.
Indications for Use:
The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
- 318 3.75 -
- Lifecore® Biomedical Restore 3,75 -
- Zimmer® Dental Taper-lock 4.0 .
- Sterngold Implamed® 3.75 -
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Nobel Biocare AB C/O Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K043042
Trade/Device Name: Procera® Implant Bridge Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 3, 3004 Received: November 4, 2004
Dear Ms. Mason:
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 vour 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. Mason
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 vour 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/dsma/dsmamain.html
Sincerely 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
510(k) Number (if known): K043042
Device Name: Procera® Implant Bridge
Indications For Use:
The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
• 3i® 3.75
- Lifecore® Biomedical Restore 3.75
· Zimmer® Dental Taper-lock 4.0
· Sterngold Implamed® 3.75
Prescription Use X (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)
Ken Moley ka MSR
(Division Sign-Off) Page 1 of 1 . . pital, Division of Ane Infection Control.
510(k) Number: K043042
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