(101 days)
Not Found
No
The 510(k) summary describes a physical dental abutment made of PMMA and Titanium Alloy, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a temporary abutment for dental implants, used to maintain, stabilize, and shape soft tissue during the healing phase, not for treating a disease or condition.
No
Explanation: The device is described as a temporary abutment used for crown and bridge restorations and soft tissue shaping during healing, not for diagnosing medical conditions.
No
The device description explicitly states the device is made of polymethyl methacrylate (PMMA) with a Titanium Alloy inlay, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for temporary dental restorations and soft tissue management. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a physical implant component made of PMMA and Titanium Alloy, designed to be placed on dental implants. This is consistent with a medical device used in a surgical or dental procedure, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Reagents or test kits
- Diagnostic purposes (identifying diseases, conditions, etc.)
The device is a dental implant abutment, which is a type of medical device used in dentistry.
N/A
Intended Use / Indications for Use
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Straumann Temporary Abutments VITA CAD-Temp are temporary abutments intended for placement on Straumann Bone Level and Straumann Tissue Level implants of corresponding diameter. The temporary abutments are made of polymethyl methacrylate (PMMA), 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing were performed to ensure that the devices subject to this 510(k) Premarket Notification function as intended and that design input matches design output. Testing included:
- Performance Testing
FDA guidance document "Class II Special Controls Guidance. Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."- Fatigue testing was performed in accordance to the test set-up of the guidance document for systems that include polymeric components. Compressive and shear (lateral) forces were tested; successful testing was measured by the predetermined acceptance criteria which was based on the predicate devices. Angled abutment testing was not performed as no angled devices were proposed. The proposed devices met or surpassed the acceptance criteria.
- Sterilization Validation
i. Sterilization validation was carried out in accordance with ISO 17665-1 (overkill method, partial cycle): Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO 17665-2: First edition 2009-01-15 Technical Specification Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.- Requirements were met; there were no deviations to the applicable standards.
The results from the testing conducted demonstrated that the Straumann Temporary Abutments VITA CAD-Temp function as intended and met the predetermined acceptance criteria.
The results of the performance bench testing and risk analysis indicate that the Straumann Temporary Abutments VITA CAD-Temp are substantially equivalent to the named predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072679, K070478, K051717, K111357
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Straumann Temporary Abutments, PMMA Traditional 510(k) Section 5: 510(k) Summary
straumann
NOV 2 2012
1. Applicant's Name and Address
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 Requlatory Project Manager
- Date of Submission: 2. July 23, 2012
3. Name of the Device
| Trade Name: | Straumann Temporary Abutments VITA CAD-Temp |
|---|---|
| Common Name: | Temporary Abutments |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | §872.3630 |
ર. Description of the Device
Straumann Temporary Abutments VITA CAD-Temp are temporary abutments intended for placement on Straumann Bone Level and Straumann Tissue Level implants of corresponding diameter. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy inlay.
6. Intended Use of the Device
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.
1
122192
7. Technological Characteristics
The proposed devices are substantially equivalent to the currently marketed devices. They share the same indication for use, prosthetic platforms, implant/abutment connections, fundamental operating principles, and contact duration of up to six months. Changes to the proposed devices are listed below followed by a comparison table, Table 1, listing each proposed and predicate device and the respective changes:
- · Material change from PEEK to PMMA, and from Titanium Alloy to PMMA,
- · Design changes of the coronal aspects of the abutments including length and diameter.
| Change | Proposed Device | Predicate Device |
|---|---|---|
| NC Temporary Abutment, PMMA | NC Temporary Abutment, PEEK | |
| Material | PMMA, polymethyl methacrylate | PEEK, polyetheretherketone |
| Length | 14.65mm | 14.75mm |
| Change | Proposed Device | Predicate Device |
| RC Temporary Abutment, PMMA | RC Temporary Abutment, PEEK | |
| Material | PMMA, polymethyl methacrylate | PEEK, polyetheretherketone |
| Length | 16.30mm | 16.40mm |
| Change | Proposed Device | Predicate Device |
| RN Temporary Abutment, PMMA | RN synOcta Temporary Abutment, PEEK | |
| Material | PMMA, polymethyl methacrylate | PEEK, polyetheretherketone |
| Change : | Proposed Device | Predicate Device |
| WN Temporary Abutment, PMMA | RN synOcta Temporary Abutment, PEEK | |
| Material | PMMA, polymethyl methacrylate | PEEK, polyetheretherketone |
| Diameter | 10.10mm | 7.0mm |
| Implant | Ø 4.8mm Wide Neck Tissue | Ø3.3, 4.1 and 4.8mm Regular Neck |
| Compatibility | Level Implant | Tissue Level Implants |
| Prosthetic | ||
| Platform | Ø 6.5mm | Ø 4.5mm |
| Change | Proposed Device | Predicate Device |
| NNC Temporary Abutment, PMMA | NNC Post for Temporary Restoration, - | |
| Material | PMMA, polymethyl methacrylate | |
| Titanium Alloy Inlay, Ti6Al7Nb | Titanium Alloy, Ti6Al7Nb | |
| Diameter | 5.0mm | 3.70 mm |
Table 1: Comparison Table
8. Performance Testing
Verification and validation testing were performed to ensure that the devices subject to this 510(k) Premarket Notification function as intended and that design input matches design output. Testing included:
Revised 510(k) Summary Straumann, USA, LLC
2
-
- Performance Testing
- FDA guidance document "Class II Special Controls Guidance ﻨﺖ. Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
-
- Fatigue testing was performed in accordance to the test set-up of the guidance document for systems that include polymeric components. Compressive and shear (lateral) forces were tested; successful testing was measured by the predetermined acceptance criteria which was based on the predicate devices. Angled abutment testing was not performed as no angled devices were proposed. The proposed devices met or surpassed the acceptance criteria.
-
-
- Sterilization Validation
- i. Sterilization validation was carried out in accordance with ISO 17665-1 (overkill method, partial cycle): Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO 17665-2: First edition 2009-01-15 Technical Specification Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
-
- Requirements were met; there were no deviations to the applicable standards.
-
9. Conclusion
The results from the testing conducted demonstrated that the Straumann Temporary Abutments VITA CAD-Temp function as intended and met the predetermined acceptance criteria.
The results of the performance bench testing and risk analysis indicate that the Straumann Temporary Abutments VITA CAD-Temp are substantially equivalent to the named predicate devices.
Revised 510(k) Summary Straumann, USA, LLC
3
Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another person, represented by three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 2012
Straumann USA, Limited Liability Company Ms. Elaine Alan Regulatory Project Manager 60 Minuteman Road Andover, Massachusetts 01810
Re: K122192
Trade/Device Name: Straumann Temporary Abutments VITA CAD-Temp Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 8, 2012 Received: October 9, 2012
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 either 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
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
ph foc
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Straumann Temporary Abutments VITA CAD-Temp
Indications for Use:
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.
X Prescription Use (Part 21 CFR 801 Subpart D) 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)
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Dental Devices
510(k) Number: K122190
Response Letter: K122192 Straumann Temporary Abutments, PMMA Straumann, USA, LLC
October 5, 2012 Page 7 of 44
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