(205 days)
No
The description focuses on the material and mechanical function of a titanium base for dental abutments used with a CAD/CAM system. There is no mention of AI or ML.
No.
The device provides support for dental restorations and does not have a therapeutic effect.
No
The device description indicates it is a titanium base for CAD/CAM abutments and restorations, providing structural support rather than diagnosing conditions.
No
The device description clearly states the device is a "Titanium Base for CAD/CAM" made from commercially pure titanium, indicating it is a physical hardware component, 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 states that the device is used in conjunction with implants to provide support for crowns and bridges in the maxillary and/or mandibular arch. This is a surgical/dental device used directly on a patient for structural support.
- Device Description: The description details the materials and function of the titanium base as a foundation for customized abutments and restorations. This further reinforces its role as a component of a dental implant system used in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as part of a dental restoration.
N/A
Intended Use / Indications for Use
Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.
Product codes
NHA
Device Description
Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083496, K073553, K040170, K032263, K083297
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
APR 2 0 2011
THOMMEN MEDICAL AG SPI® Titanium Base for CAD/CAM K102804
April 19, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Thommen Medical AG
Hauptstrasse 26d
CH-4437 Waldenburg, Switzerland | |
|----------------------------|---------------------------------------------------------------------------|--------------------|
| | Telephone: | +41 61 965 90 20 |
| | Fax: | +41 61 965 90 21 |
| Official Contact: | Orlando Antunes | |
| Representative/Consultant: | Linda K. Schulz, BSDH, RDH | |
| | Kevin A. Thomas, PhD | |
| | PaxMed International, LLC | |
| | 11234 El Camino Real, Suite 200 | |
| | San Diego, CA 92130 | |
| | Telephone: | +1 (858) 792-1235 |
| | Fax: | +1 (858) 792-1236 |
| | Email: | lschulz@paxmed.com |
| | | kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | SPI® Titanium Base for CAD/CAM |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| 21 CFR 872.3630, Class II | |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
INTENDED USE
Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.
1
DEVICE DESCRIPTION
Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Laya System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.
EQUIVALENCE TO MARKETED DEVICE
Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, SPI® Titanium Base for CAD/CAM is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, cleared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553;
FRIADENT GmbH, FRIADENT PLUS Dental Implant Systems, cleared under K040170;
Implant Innovations, Inc., 3i Patient-Specific Dental Abutments and Overdenture Bars. cleared under K032263; and
Sybron Implant Solutions GmbH, Pitt-Easy Dental Implant System, cleared under K083297.
The subject device and the predicate devices are all made of commercially pure titanium or titanium alloy. The subject and predicate devices encompass the same range of physical dimensions, including sizes and configuration. All of the devices consist of a titanium base/post used in CAD/CAM fabrication of custom dental implant abutments/restorations and an abutment screw. The custom CAD/CAM component is bonded to the titanium base. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in technological characteristics do not raise new issues of safety or efficacy. Information provided to demonstrate substantial equivalence included a detailed list of subject and predicate device characteristics.
Overall, SP1® Titanium Base for CAD/CAM has the following similarities to the predicate devices:
- . has the same intended use,
- uses the same operating principle, .
- . incorporates the same basic design,
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. .
2
.
DEVICE DESCRIPTION
Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.
EQUIVALENCE TO MARKETED DEVICE
Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, SPI® Titanium Base for CAD/CAM is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, cleared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553:
FRIADENT GmbH, FRIADENT PLUS Dental Implant Systems, cleared under K040170;
Implant Innovations, Inc., 3i Patient-Specific Dental Abutments and Overdenture Bars, cleared under K032263: and
Sybron Implant Solutions GmbH, Pitt-Easy Dental Implant System, cleared under K083297.
The subject device and the predicate devices are all made of commercially pure titanium or titanium alloy. The subject and predicate devices encompass the same range of physical dimensions, including sizes and configuration. All of the devices consist of a titanium base/post used in CAD/CAM fabrication of custom dental implant abutments/restorations and an abutment screw. The custom CAD/CAM component is bonded to the titanium base. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in technological characteristics do not raise new issues of safety or efficacy. Information provided to demonstrate substantial equivalence included a detailed list of subject and predicate device characteristics.
Overall, SP1® Titanium Base for CAD/CAM has the following similarities to the predicate devices:
- . has the same intended use,
- . uses the same operating principle,
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. ●
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 stylized depiction of an eagle or bird with three wing-like strokes above a wavy line, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Thommen Medical AG C/O Linda K. Schulz PaxMed International. LLC Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130
APR 2 0 2011
Re: K102804
Trade/Device Name: SPI® Titanium Base for CAD/CAM Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 15, 2011 Received: April 18, 2011
Dear Mrs. Schulz:
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 - Mrs. Schulz
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,
Nh for
Anthony 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
510(k) Summary
Indications for Use
K102804 510(k) Number:
Device Name:
SPI® Titanium Base for CAD/CAM
Indications for Use:
Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: