(133 days)
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No
The summary describes a mechanical dental implant abutment and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device, SPI® VARIOmulti Abutments, is described as a dental implant abutment system used to provide support for crowns, bridges, or overdentures. It is a component of a dental prosthetic system, not a device directly involved in therapy or treatment beyond providing structural support for restorations.
No
Explanation: The device description states that the product is a dental implant abutment used to support crowns, bridges, or overdentures. Its purpose is structural support for dental prosthetics, not the detection, diagnosis, or monitoring of a medical condition.
No
The device description clearly states that the device is a physical dental implant abutment, which 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 clearly states that the abutments are for providing support for crowns, bridges, or overdentures in the maxillary and/or mandibular arch. This is a mechanical function within the body.
- Device Description: The description details a dental implant abutment used for prosthetic restorations. This is a medical device used for structural support and connection within the oral cavity.
- 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 specifically designed to perform tests on biological samples outside of the body to gain diagnostic or other health-related information. This device is a physical component used within the body for structural support.
N/A
Intended Use / Indications for Use
Thommen SPI® VARIOmulti Abutments are intended to be used in conjunction with SPT® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
SPI® VARIOmulti Abutments are dental implant abutments for use with the SP1® 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. VARIOmulti Abutments are appropriate for supporting laboratory cast frameworks as well as machined titanium frameworks using the Nobel Biocare Procera® Implant Bridge Titanium.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxillary and/or mandibular arch
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.)
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Ko72856
SPI® VARIOmulti Abutment
510(k) Summary
Thommen Medical AG SPI® VARIOmulti Abutment
たこと 15 : . .
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 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: | SPI® VARIOmulti Abutment |
|---|---|
| Common Name: | Dental implant abutment |
| Classification Regulations: | 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 SPI® VARIOmulti Abutments are intended to be used in conjunction with SPT® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
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DEVICE DESCRIPTION
SPI® VARIOmulti Abutments are dental implant abutments for use with the SP1® 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. VARIOmulti Abutments are appropriate for supporting laboratory cast frameworks as well as machined titanium frameworks using the Nobel Biocare Procera® Implant Bridge Titanium.
EQUIVALENCE TO MARKETED PRODUCT
Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI® VARIOmulti Abutments are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
FEB 15 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thommen Medical, AG C/O Ms. Linda K. Schulz, RDH, BSDH Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K072856
Trade/Device Name: SPI® VARIOmulti Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 6, 2008 Received: February 7, 2008
Dear Ms. Linda K. 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.
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. Linda K 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 (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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syllte Y. Michau Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
SPI® VARIOmulti Abutment Device Name:
Indications for Use:
Thommen SPI® VARIOmulti 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, 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)
oncurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kunnen
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072854
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