(121 days)
Not Found
No
The document describes a mechanical dental implant abutment and does not mention any AI or ML components or functions.
No
The device is an abutment for dental implants, providing support for crowns or bridges, which is a structural component and not directly involved in treating or preventing a disease.
No
The device is a dental implant abutment used to support crowns or bridges, not to diagnose a condition.
No
The device description clearly states that the device is a titanium dental implant abutment, which is a physical 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 or bridges in the maxillary and/or mandibular arch. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a titanium dental implant abutment. This is a physical component used in a surgical procedure and subsequent prosthetic restoration.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Thommen SPI® VARIO Angled Abutments are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
SPI® VARIO Angled Abutments are titanium dental implant abutments for use with the SP1® Dental Implant system. They connect with the internal hex feature of the implant, have a precision fit interface with the prosthetic attachment, and are intended for screw retained restorations in single unit and small multi-unit solutions. SPI VARIO Angled Abutments are designed for correction of implant divergence and can be used in combination restorations with SPI VARIO abutments.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.
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.
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
NOV 1 0 2011
510(k) Summary
SPI® VARIO Angled Abutment
510(k) Summary
Thommen Medical AG SPI® VARIO Angled Abutment K111984
October 27, 2011
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland +41 61 965 90 20 Telephone: Fax: +41 61 965 90 21
Official Contact:
Minna Buser, RA Manager
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: Ischulz@paxmed.com kthomas@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | SPI® VARIO Angled Abutment |
|---|---|
| Common Name: | Dental implant abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Classification Regulations: | 21 CFR 872.3630, Class II |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
1
510(k) Summary
SPI® VARIO Angled Abutment
INTENDED USE
Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.
DEVICE DESCRIPTION
SPI® VARIO Angled Abutments are titanium dental implant abutments for use with the SP1® Dental Implant system. They connect with the internal hex feature of the implant, have a precision fit interface with the prosthetic attachment, and are intended for screw retained restorations in single unit and small multi-unit solutions. SPI VARIO Angled Abutments are designed for correction of implant divergence and can be used in combination restorations with SPI VARIO abutments.
EQUIVALENCE TO MARKETED DEVICE
Thommen Medical AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical devices SPI® VARIO Angled Abutment 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:
Thommen Medical AG, SP1® Dental Implant Abutments cleared under K031747 Thommen Medical AG, SPI® VARIOmulti Abutment cleared under K072856 Thommen Medical AG, SPI® VARIOmulti Angled Abutment cleared under K090153
The subject device and the predicate devices have the same intended use, the same technological characteristics, are made of the same materials, and encompass the same range of physical dimensions. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.
Overall, SP1® VARIO Angled Abutment 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES-USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 0 2011
Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs Consultant PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K111984
Trade/Device Name: SPI® VARIO Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 27, 2011 Received: October 28, 2011
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.
3
Page 2 - Ms. 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.
h for
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
4
K///984
SPI® VARIO Angled Abutment
Indications for Use
510(k) Number: K111984
SPI® VARIO Angled Abutment Device Name:
Indications for Use:
Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or 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)
Susan Rums
Page 1 of /
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111984