(237 days)
No
The summary describes a CAD/CAM system for designing and milling dental abutments, which is a standard digital manufacturing process and does not mention or imply the use of AI or ML for design, analysis, or manufacturing.
No
The device is an abutment for dental implants, used to support crowns, bridges, and overdentures, which is a restorative function, not a therapeutic one.
No
This device, the Thommen Milling Abutment for CAD/CAM, is an implant component used to support dental prosthetics. Its function is to provide physical support for crowns, bridges, and overdentures, not to diagnose a condition or disease.
No
The device description clearly states it is a physical abutment made of titanium, available in different sizes, and supplied with a screw. It is used in conjunction with a CAD/CAM system for design but the device itself is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for crowns, bridges, and overdentures in the maxillary and/or mandibular arch. This is a structural and mechanical function within the body.
- Device Description: The device is a milling abutment used to fabricate a customized abutment for dental implants. This is a physical component used in a dental restoration process.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used for diagnosis, monitoring, or screening.
- Using reagents or calibrators.
The device is a dental prosthetic component used in conjunction with dental implants. It is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures.
All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Milling Abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM System to fabricate a customized abutment made of titanium. Each patient-specific abutment is individually prescribed by the clinician. Minimum wall thickness allowed for the final abutment is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height of the abutment is no greater than 15 mm and no shorter than 4.5 mm. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. Final abutments are to be sterilized prior to intraoral placement.
Milling Abutment for CAD/CAM is available in five diameters (3,5 mm, 4,0 mm, 5,0 mm, 6,0 mm) and two heights (12 mm and 15 mm). The Ø3.5 mm abutment is provided in the 12 mm height. All other diameters are provided in the 15 mm height. Each abutment is supplied with a corresponding screw. Milling Abutment for CAD/CAM is compatible with the Thommen Implant System ELEMENT and CONTACT implants.
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
dental laboratory, clinician
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included the following: sterilization according to ISO 17665-1 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 Sterilization of health care products – Moist heat - Part 2: Guidance on the application of ISO 17665-1; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process which determined that no further biocompatibility testing is required because all materials and processing are identical to the abutments cleared in K031747: Input/output validation for the Thommen Medical library performed to ensure accuracy and conformance to the parameters outlined for the Thommen Milling Abutment for CAD/CAM. Validation confirmed that accuracy was consistent and parameter limits were maintained in final device manufacturing. Static and dynamic compression -bending testing were performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
Thommen Medical AG c/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K151984
Trade/Device Name: Milling Abutment for CAD/CAM Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 10, 2016 Received: February 11, 2016
Dear Ms. 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.
1
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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina Kiang S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Milling Abutment for CAD/CAM
Indications for Use (Describe)
Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures.
All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
Thommen Medical AG
Milling Abutment for CAD/CAM K151984
March 7, 2016
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Thommen Medical AG | |
|---|---|---|
| Neckarsulmstrasse 28 | ||
| 2540 Grenchen, Solothurn | ||
| Switzerland | ||
| Telephone: | +41 61 965 90 20 | |
| Fax: | +41 61 965 90 21 | |
| Official Contact | Daniel Snetivy | |
| Chief Technology Officer | ||
| Representative/Consultant | Linda Schulz, BSDH, RDH | |
| Floyd G. Larson | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400 | ||
| San Diego, CA 92130 | ||
| Telephone: | +1 (858) 792-1235 | |
| Fax: | +1 (858) 792-1236 | |
| Email: | lschulz@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Milling Abutment for CAD/CAM |
|---|---|
| Common Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Classification Regulation: | 21 CFR 872.3630, Class II |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
4
INDICATIONS FOR USE
Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures.
All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.
| K122295 | CORE 3D Abutment System for
Digital Prosthetic Solutions | CORE 3D Protech, S.L. | Primary Predicate |
|------------------------------------------|-------------------------------------------------------------|-----------------------|-------------------|
| K073713 | Blue Sky Bio Dental Implant | Blue Sky Bio, LLC | Reference |
| | System | | Predicate |
| K031747
SPI® Dental Implant Abutments | | Thommen Medical, AG | Reference |
| | | | Predicate |
| K090154 | SPI® Dental Implant, INICELL® | Thommen Medical, AG | Reference |
| | | | Predicate |
PREDICATE INFORMATION
DEVICE DESCRIPTION
The Milling Abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM System to fabricate a customized abutment made of titanium. Each patient-specific abutment is individually prescribed by the clinician. Minimum wall thickness allowed for the final abutment is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height of the abutment is no greater than 15 mm and no shorter than 4.5 mm. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. Final abutments are to be sterilized prior to intraoral placement.
Milling Abutment for CAD/CAM is available in five diameters (3,5 mm, 4,0 mm, 5,0 mm, 6,0 mm) and two heights (12 mm and 15 mm). The Ø3.5 mm abutment is provided in the 12 mm height. All other diameters are provided in the 15 mm height. Each abutment is supplied with a corresponding screw. Milling Abutment for CAD/CAM is compatible with the Thommen Implant System ELEMENT and CONTACT implants.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included the following: sterilization according to ISO 17665-1 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 Sterilization of health care products – Moist heat - Part 2: Guidance on the application of ISO 17665-1; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process which determined that no further biocompatibility testing is required because all
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510(k) Summary Page 3 of 4
materials and processing are identical to the abutments cleared in K031747: Input/output validation for the Thommen Medical library performed to ensure accuracy and conformance to the parameters outlined for the Thommen Milling Abutment for CAD/CAM. Validation confirmed that accuracy was consistent and parameter limits were maintained in final device manufacturing. Static and dynamic compression -bending testing were performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles predicate devices shown above. Below are summary tables showing technical comparison between the subject device and the primary predicate devices.
| Subject Device | Primary Predicate Device |
|---|---|
| Thommen Medical AG | CORE 3D Protech, S.L. |
| Milling Abutment for | |
| CAD/CAM | Core 3D Abutment System for Digital Prosthetic Solutions |
| K151984 | K122295 |
| Indications for use | |
| Thommen Milling abutments for | |
| CAD/CAM are intended to be | |
| used in conjunction with | The CORE 3D abutment system for digital prosthetic solutions are dental abutments |
| placed into a dental implant to provide support for dental prosthetic restorations. The | |
| abutments include: | |
| Thommen System dental | |
| implants in the maxillary and /or | |
| mandibular arch to provide | |
| support for crowns, bridges and | |
| overdentures. | • Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM |
| designed superstructure may be fitted to complete a two-piece dental abutment; | |
| • Titanium Abutment Blanks with a pre-machined implant connection where the upper | |
| portion may be custom-milled in accordance with a patient-specific design using | |
| CAD/CAM techniques | |
| All digitally designed | |
| abutments for use with | |
| Thommen Milling abutments | |
| for CAD/CAM are intended | |
| to be sent to a Thommen | |
| validated milling center for | |
| manufacture. | • Abutment Screws to permanently fix the abutments to the underlying implant. Core 3D |
| abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges | |
| and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations. | |
| Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D | |
| allowable range of design specifications and be provided as straight abutments only. | |
| Core 3D abutments and are compatible for use with the following dental Implants: | |
| • Nobel Biocare Brånemark System (K022582, K934825) | |
| • Zimmer Tapered Screwvent (K013227, K061410, K072589) | |
| Design | |
| CAD/CAM Blank | CAD/CAM Blank, |
| Titanium Base | |
| Cement-retained | Cement-retained |
| Single-unit, | |
| Multi-unit | Single-unit, |
| Multi-unit | |
| 3.5 - 6.0 | 3.5 - 5.7 |
| Internal Hex | Internal Hex, |
| External Hex |
The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments. Both abutments are being used in conjunction with dental implants for the purpose of supporting dental prostheses and are CAD/CAM custom abutments fabricated at a milling center.
6
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, gingival height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and to be sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.