(64 days)
K0910153, k80063
Not Found
No
The summary describes a mechanical dental implant abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a dental implant abutment used to support crowns, bridges, or overdentures, which is a restorative function, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device description clearly states its purpose is to provide support for dental restorations (splinted crowns, bridges, or overdentures) in conjunction with dental implants. It is a prosthetic component for treatment, not a tool for identifying or characterizing a disease or condition.
No
The device description clearly states it is a 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 clearly states that the abutments are used to provide support for dental restorations (crowns, bridges, overdentures) in the mouth. This is a mechanical function within the body.
- Device Description: The description details a physical component used in dental implant procedures.
- 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) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be implanted in the body for structural support.
N/A
Intended Use / Indications for Use
Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.
Product codes
NHA
Device Description
SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K0910153, k80063
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
MAR 2 7 2009
510(k) Summary
Thommen Medical AG Special 510(k): Device Modification
SPI® VARIOmulti Angled Abutment
Orlando Antunes
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:
Representative/Consultant:
Linda K. Schulz or Floyd G. Larson 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 flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
SPI® VARIOmulti Angled Abutment Dental implant abutment Endosseous dental implant abutment 21 CFR 872.3630, Class II NHA Dental Products Panel Dental Devices Branch
INTENDED USE
Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.
1
DEVICE DESCRIPTION
SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.
EQUIVALENCE TO MARKETED PRODUCT
Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPT® VARIOmulti Angled Abutments are substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
MAR 2 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thommen Medical, AG C/o Ms. Linda K. Schulz, RDH, BSDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K090153
Trade/Device Name: SPI® VARIOmulti Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2009 Received: January 22, 2009
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-ffor 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suita y. Michael O.m.d.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SPI® VARIOmulti Angled Abutment
510(k) Summary
Indications for Use
510(k) Number (if known); K0910153
Device Name:
SPI® VARIOmulti Angled Abutment
Indications for Use:
Thommen SPT® VARIOmulti Angled Abutments are intended to be used in conjunction with SPT® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.
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 Punner
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k80063