(10 days)
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The device covered by this submission is an abutment.
The basal portion of the abutment has an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw restorations.
The provided document is a 510(k) summary for a dental implant abutment (Straumann RN synOcta UCLA Gold Abutment). It focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.
Therefore, most of the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), and training set information is not applicable or available in this document.
Here's a breakdown of the information that can be extracted and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document does not describe performance-based acceptance criteria or provide specific performance metrics for the device. The basis for substantial equivalence is "intended use, material, and design" to a predicate device, not a new performance study against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. There is no "test set" in the context of a performance study described in this document. The submission is based on comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. No MRMC study is mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable. There is no performance study against a ground truth described in this document.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical dental abutment, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set or ground truth for it is relevant to this submission.
Summary of what is present in the document relevant to a regulatory submission:
- Device Name: Straumann RN synOcta UCLA Gold Abutment
- Intended Use: To be placed into dental implants to provide support for prosthetic restorations such as a crown or bridge.
- Basis for Substantial Equivalence: The device is substantially equivalent in intended use, material, and design to the 1.5mm synOcta abutments and gold copings cleared under K022859 (the predicate device). The intended use is stated to be identical.
- Regulatory Classification: Class III, Product Code NHA (Endosseous Implant).
- 510(k) Number: K041295
In conclusion, this document is a 510(k) summary for a medical device that establishes substantial equivalence based on fundamental design, material, and intended use comparison to a predicate device, rather than through a new performance study against specific acceptance criteria. Therefore, the detailed information about studies, sample sizes, experts, and ground truth for performance evaluation is not included.
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MAY 2 4 2004
KUJINGS
ATTACHMENT 7 - 510(k) Summary
Applicant's Name and Address 1.
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-0791 Fax Number: John King Contact Person: Regulatory Affairs
Name of the Device 2.
Trade Name: Common Name: Classification Name: Straumann RN synOcta UCLA Gold Abutment Dental implant abutment Endosseous dental implants 21 CFR 872.3640
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
Straumann 1.5mm synOcta Abutment with Gold Coping (K022859)
Description of the Device 4.
The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The device covered by this submission is an abutment.
The basal portion of the abutment has an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw restorations.
5. Intended Use of the Device
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge.
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6. Basis for Substantial Equivalence
The Straumann RN synOcta UCLA gold abutment is substantially equivalent in intended use, material, and design to the 1.5 mm synOcta abutments and gold copings cleared under K022859. The intended use of the subject abutiment is identical to the predicate abutment.
5 l0(k) RN synOcta UCLA Gold Abutment
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Image /page/2/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. In the center of the seal is a stylized graphic of three wavy lines, which are meant to represent the flow of people.
Public Health Service
MAY 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Mr. John King Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K041295
Trade/Device Name: RN SynOcta UCLA Gold Abutment For the Straumann Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 13, 2004 Received: May 14, 2004
Dear Mr. King:
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. King
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,
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): K041295
Device Name: RN synOcta UCLA Gold Abutment
Indications for Use:
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
AND/OR Prescription Use _ x (Part 21 CFR 801 Subpart D)
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 Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
Page 1 of _
510(k) Number. K041105
§ 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.)