(186 days)
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
The Straumann P.004 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 devices covered in this submission are abutments.
The basal portion of the abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. 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-retained restorations.
This documentation describes a 510(k) premarket notification for a dental abutment, P.004 RC Gold Abutment. It explicitly states that the device is substantially equivalent to a predicate device and notes it has the same material composition, basic design, and fundamental operating principles.
Therefore, the document does not contain information related to acceptance criteria, device performance testing, or studies involving AI/ML, human readers, or ground truth establishment. The FDA's 510(k) clearance process for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive performance studies as might be seen for novel devices or software with AI/ML components.
To directly answer your request based on the provided text, I must state that the requested information (items 1-9) about acceptance criteria and device performance studies is not present in the provided 510(k) summary. This document details a traditional medical device submission (dental abutment), not a software or AI/ML device submission.
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Section I 510(k) SUMMARY
AUG 3 1 2007
Applicant's Name and Address 1.
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: February 23, 2007
2. Name of the Device
| Trade Name: | P.004 RC Gold Abutment |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| 21 CFR 872.3640 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Straumann P.004 Dental Implants, K062129 synOcta Gold Abutment, K041295
4. Description of the Device
The Straumann P.004 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 devices covered in this submission are abutments.
The basal portion of the abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. 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-retained restorations.
5. Intended Use of the Device
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.
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6. Technological Characteristics
The proposed abutment is substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices.
,
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human profiles facing to the right, creating a sense of movement and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
AUG 3 1 2007
Re: K070549 Trade/Device Name: P.004 Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 23, 2007 Received: August 24, 2007
Dear Ms. Alan:
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. Alan
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 (OS) 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 (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/industry/support/index.html.
Sincerely yours,
Sylvia y. Michael m.D.
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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K070549
INDICATIONS FOR USE STATEMENT
Device Name: P.004 Abutment
Indications for Use:
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
× AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Susan Runn
(Division Sign-Off)
| Page 1 of 1 | Division of Anesthesiology, General HospitalInfection Control, Dental Devices |
|---|---|
| 510(k) Number: | K070549 |
Straumann US Page 5
§ 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.)