(245 days)
The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.
The internal connection of the Neoss Access Abutment provides a solution with a minimum height of the complete prosthesis of 5 mm and allows an overall implant alignment of up to 60 degrees without restraining the fabrication of a multiple-unit screw-retained restoration.
The angulated 10°, 20° and 30° abutments are intended for multi-unit cases in order to improve the position of the screw access hole.
Restorations can be based on Neolinks being incorporated into gold or ceramic frameworks, or solid titanium and ceramics frameworks. The frameworks are then tightened with prosthetic screws onto the Neoss Access Abutments.
The Neoss Access Abutments are dental abutments.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Recommended requirements per "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004" | The abutment fulfills the recommended requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "performed testing" but does not detail the number of units tested.
- Data Provenance: Not explicitly stated. Given that the manufacturer is Neoss Ltd (UK) and the submission is to the FDA (USA), the testing was likely conducted in a controlled laboratory environment, but the location of the lab or the origin of any materials used is not specified. It is a prospective test specifically for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This device is a physical dental abutment, and its performance is assessed against engineering and material requirements, not against human expert interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Performance testing of a physical device against engineering standards typically involves direct measurement and comparison to predefined thresholds, not a multi-expert adjudication process.
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:
- MRMC Study: No. This is a physical medical device (dental abutment), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Ground Truth: The "ground truth" for this device's performance is established by the "recommended requirements" outlined in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." These requirements specify the mechanical, material, and biocompatibility properties the abutment must meet.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, but not a data-driven training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. (See point 8).
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SECTION 2.
A. 510(k) SUMMARY
MAR 2 2009
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Neoss Ltd summary for the Neoss Access Abutments
| SUBMITTER'S NAME: | Neoss Ltd |
|---|---|
| ADDRESS: | Windsor House |
| Cornwall Road | |
| Harrogate, HG1 2PW, UK | |
| CONTACT PERSON: | Fredrik Engman |
| TELEPHONE NUMBER: | +44 (0) 1423 817733 , +46 (0)709 792 892 |
| FAX NUMBER: | +44(0) 1423 817744 |
| fredrik.engman@neoss.com | |
| DATE OF SUBMISSION: | June 2, 2008 |
1. Identification of device
Classification name: Proprietary Name: Common Name: Classification Status: Product Codes:
Abutment, Dental, Endosseous Neoss Access Abutments Dental Abutment Class II per regulations 872.3630 NHA
2. Equivalent devices
K061477 Nobel Biocare Multi-Unit Abutment
3. Description of the Device
The internal connection of the Neoss Access Abutment provides a solution with a minimum height of the complete prosthesis of 5 mm and allows an overall implant alignment of up to 60 degrees without restraining the fabrication of a multiple-unit screw-retained restoration.
The angulated 10°, 20° and 30° abutments are intended for multi-unit cases in order to improve the position of the screw access hole.
Restorations can be based on Neolinks being incorporated into gold or ceramic frameworks, or solid titanium and ceramics frameworks. The frameworks are then tightened with prosthetic screws onto the Neoss Access Abutments.
4. Intended use
The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
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Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.
Ko81851
5. Technological characteristics, comparison to predicate device.
Substantial equivalence of the Neoss Access Abutments is based on the design similarities between the predicate Nobel Biocare Multi-Unit Abutments and Neoss Access abutments since they are very similar in terms of material, size, basic design and intended use.
6. Discussion of performance testing.
The Neoss Access Abutments has, where applicable, been tested in accordance to the Guideline (Doc. No. 0043 - Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004) and the test results show that the abutment fills the recommended requirements.
7. Conclusion
Based on comparison and performed testing, the Neoss Access Abutments are substantially equivalent to the predicate Nobel Biocare Multi-Unit Abutments and do not generate additional risks.
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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 stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all capital letters and is black.
Public Health Service
2 2009 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Fredrik Engman CTO Neoss Limited Windsor House, Cornwall Road Harrogate, Yorkshire UNITED KINGDOM HGI 2PW
Re: K081851
Trade/Device Name: Neoss Access Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 27, 2009 Received: March 2, 2009
Dear Mr. Engman:
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 - Mr. Engman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Serita Y. Michael Dmd.
Ginette Y. Michaud, M.D. Acting 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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A. INDICATIONS FOR USE
510(k) Number: K081851
Device Name: Neoss Access Abutments
Indications for Use:
The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use___x_ OR Over the Counter Use (Per 21 CFR 801.109)
Susan Puarez
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081851
§ 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.)