(15 days)
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.
The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems:
Nobel Biocare Brånemark System Nobel Biocare Replace Select
The Procera Implant Bridge can be used at the implant level of the following implant systems:
Nobel Biocare Replace
Nobel Biocare Steri-Oss HL Nobel Biocare Novum
Nobel Biocare Novum
Straumann Dental Implants
Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6,5
The Procera Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept
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 and abutment interfaces are modeled after similar interfaces currently available for the predicate devices listed.
This document describes a 510(k) premarket notification for the Procera® Implant Bridge, a dental bridge framework. However, the provided text does not contain acceptance criteria for device performance, nor does it detail any specific studies (e.g., clinical trials or performance tests with statistical results) that directly prove the device meets such criteria.
The document primarily focuses on:
- Device Description: What the device is and how it's made (titanium, custom-made).
- Intended Use/Indications for Use: What the device is for (restoring chewing function in partially or totally edentulous jaws) and compatible implant systems.
- Substantial Equivalence: Comparing the device to legally marketed predicate devices.
- Regulatory Information: Classification, product code, and relevant regulations.
Here's an analysis based on the provided text for the requested information, highlighting what is not present:
1. Table of acceptance criteria and reported device performance
Not present in the document. The submission is for substantial equivalence to predicates, implying that if it's materially similar to already approved devices, it's considered safe and effective. There are no specific performance metrics or acceptance criteria listed for the Procera® Implant Bridge itself, nor are there reported results of performance tests against such criteria.
2. Sample size used for the test set and the data provenance
Not applicable. No specific test set or study data are mentioned for this device. The submission relies on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment is described as there's no performance study detailed.
4. Adjudication method for the test set
Not applicable. No test set or related adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental implant component, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies or AI improvement metrics are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth data is mentioned for this 510(k) submission.
8. The sample size for the training set
Not applicable. As the device is not an AI/ML algorithm or software, there is no training set in the context of data-driven models.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there's no ground truth establishment for it.
Summary of what the document states about "Performance Standards":
The document mentions in section 1.5 "Performance Standards": "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA was identified as applicable to this submission." This indicates that the device operates under a framework of "Special Controls," which are regulatory measures beyond general controls to provide reasonable assurance of safety and effectiveness. However, the document does not elaborate on what specific performance criteria from this guidance the device was tested against or the results of such testing. It merely states that the guidance was identified as applicable.
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MAY 2 6 2004
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '041236'. The characters are written in a simple, clear style, making them easily readable.
1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc.22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | May 10, 2004 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietaryor Model Name: | Procera® Implant Bridge |
| Legally Marketed Devices: | Nobel Biocare - Replace TiUnite Endosseous Implant (K023113)Nobel Biocare - Branemark System Implants (K022562)Steri-Oss - Steri-Oss Implants for Single Stage Placement (K963224)Straumann - ITI synOcta Meso Abutments (K033243) |
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 and abutment 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 chewing function.
The Procera® Implant Bridge can be used at the implant or abutment level of the following implant systems:
Nobel Biocare Brånemark System Nobel Biocare Replace Select
The Procera® Implant Bridge can be used at the implant level of the following implant systems:
Nobel Biocare Replace
Nobel Biocare Steri-Oss HL Nobel Biocare Novum
Nobel Biocare Novum
Straumann Dental Implants
Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6,5
The Procera® Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept
000008
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1.5 Performance Standards
The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA was identified as applicable to this submission.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2004
Nobel Biocare AB C/O Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K041236
Trade/Device Name: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051 Regulation Number: 372.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 10, 2004 Received: May 11, 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 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.
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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 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 (301) 594-4613. 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,
Carls
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
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Indications for Use
510(k) Number (if known):
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 edentulous jaws for the purpose of restoring chewing function.
The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems:
41236
•Nobel Biocare Brånemark System
·Nobel Biocare Replace Select
The Procera Implant Bridge can be used at the implant level of the following implant systems:
·Nobel Biocare Replace
· Nobel Biocare Steri-Oss HL
•Nobel Biocare Novum
·Straumann Dental Implant System Regular neck 4.8
·Straumann Dental Implant System Wide neck 6.5
The Procera Implant Bridge can be used at abulment level of the following implant systems: •Nobel Biocare ARK abutment for Teeth-in-Hour concept
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)
Sue Funnes
(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental
510(k) Number:
000007
§ 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.)