(95 days)
Not Found
No
The summary describes standard dental implant accessories (screws, caps, abutments) made of traditional materials (Titanium, PEEK). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on sterilization and shelf life, not algorithmic performance.
No.
The device components are used to protect and form tissue during the healing process, not to treat a disease or condition.
No
The device is described as healing abutments, healing caps, and closure screws intended to protect the internal configuration of dental implants and manage soft tissue during the healing process, which are therapeutic functions, not diagnostic.
No
The device description explicitly states the devices are made of Titanium and PEEK, indicating they are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that these devices (Closure Screws, healing caps, and healing abutments) are intended for use with dental implants to protect the implant and manage soft tissue during the healing process. They are physical components used in a surgical procedure, not for testing biological samples.
- Lack of IVD-related information: The text does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, based on the provided information, this device falls under the category of a dental prosthetic or surgical accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Closure Screws, healing caps, and healing abutments, are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
Customizable healing abutments made of PEEK are for up to six months.
Product codes
NHA
Device Description
The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the Straumann Tissue Level and Bone Level Dental Implant System to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights, and the material is Titanium for all Healing Abutments, Healing Caps and Closure Screws; the customizable Healing Abutments are made of polyetheretherketone (PEEK) with a Titanium Alloy inlay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Verification and validation testing were performed to ensure that the Straumann Sterile Healing Abutments, Healing Caps, and Closure Screws function as intended and that the modifications do not impact the performance of the devices. Testing included:
i. Sterilization validation in accordance with ISO 11137-1:2006: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices, and ISO 11137-2:2006: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- Requirements were met; there were not deviations to the applicable standards.
ii. Shelf Life validation in accordance ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages - Requirements were met; there were not deviations to the applicable standard.
Key Metrics
Not Found
Predicate Device(s)
K111357, K072679, K071585, K070478, K062129, K013798, K960634, K894844
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
510(K) Summary
Applicant's Name and Address 1.
Straumann USA, LLC (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 Project Manager
-
- Date of Submission: March 22, 2013
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- Name of the Device
Trade Name:
Straumann Healing Abutments Straumann Healing Caps Straumann Closure Screws
Common Name: Healing Abutment Healing Caps Closure Screws
Product Code: NHA
Classification Name: Endosseous Dental Implant Abutments
Regulation Number: §872.3630
4. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
K111357, Straumann Narrow Neck CrossFit (NNC) 03.3mm Dental Implant System
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K072679, P.004 Abutments
K071585, P.004 Healing Abutments and Closure Screws -
K070478, P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)
K062129, P.004 Implants
K013798, Prosthetic Accessories to the ITI Dental Implant System
K960634, Titanium Healing Caps
K894844, BoneFit Implant System Accessories and Instruments
5. Description of the Device
The Straumann Healing Abutments, Healing Caps, and Closure Screws are
intended for use with the Straumann Tissue Level and Bone Level Dental
Implant System to protect the inner configuration of the implant and to
maintain, stabilize and form the soft tissue during the healing process. The
JUN 2 8 2013
1
devices are available in various diameters and heights, and the material is Titanium for all Healing Abutments, Healing Caps and Closure Screws; the customizable Healing Abutments are made of polyetheretherketone (PEEK) with a Titanium Alloy inlay.
ర్. Intended Use of the Device
Closure screws, healing caps, and healing abutments are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
Customizable healing abutments made of PEEK are for use for up to six months.
7. Technological Characteristics
The proposed Sterile Healing Abutments, Healing Caps, and Closure Screws intended use, material, fundamental operating principles and overall design are identical to the predicate devices. The modification of the proposed healing components versus the currently cleared devices is from non-sterile to sterile devices. The non-significant design change of the proposed RC Conical Healing Abutments versus the currently cleared devices is to increase the diameter by 0.5mm.
8. Performance Testing
Verification and validation testing were performed to ensure that the Straumann Sterile Healing Abutments, Healing Caps, and Closure Screws function as intended and that the modifications do not impact the performance of the devices. Testing included:
- i. Sterilization validation in accordance with ISO 11137-1:2006: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices, and ISO 11137-2:2006: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2
-
- Requirements were met; there were not deviations to the applicable standards.
- ii. Shelf Life validation in accordance ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages
-
- Requirements were met; there were not deviations to the applicable standard.
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Conclusion ல்
The results from the testing conducted demonstrated that the Straumann Sterile Healing Abutments, Healing Caps, and Closure Screws function as intended and met the predetermined acceptance criteria.
The results of the verification/validation testing and risk analysis indicate that the Straumann Sterile Healing Abutments, Healing Caps, and Closure Screws perform as intended, are substantially equivalent to the named predicate devices and do not raise new issues of safety and effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. 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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Go(b) Silver Spring, MI) 20993-0002
June 28, 2013
Ms. Elaine Alan Regulatory Project Manager Straumann USA 60 Minuteman Road ANDOVER MA 01810
Re: K130808
Trade/Device Name: Straumann Healing Abutments, Healing Caps, and Closure Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 30, 2013 Received: May 31, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KISOBOR
Indications for Use Statement
510(k) Number (if known): K130808
Device Name: Straumann Healing Abutments, Healing Caps, and Closure Screws Indications for Use:
Closure Screws, healing caps, and healing abutments, are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
Customizable healing abutments made of PEEK are for up to six months.
Prescription Use X (Part 21 CFR 801 Subpart D)
ప ﺎ
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Sheena A. Green -S 2013.06.28 11:36:22 -04'00'
for Susan Runner, DDS, MA
Division Sign-Off) Jivision of Anesthestology, General Hospital ifection Control, Dental Davices
510(k) Number: K130808