(52 days)
Not Found
No
The device description and intended use are purely mechanical components for dental implants. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
No
This device is a dental implant abutment, which supports dental prosthetics and is not a therapeutic device.
No
The device, SPI® VARIOmulti Angled Abutments, is a dental implant abutment used to support crowns, bridges, or overdentures. Its purpose is structural and restorative, not to diagnose a disease or condition.
No
The device description explicitly states the abutments are made of titanium and are physical components used in dental implants, indicating it is a hardware device.
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 to provide support for dental restorations (crowns, bridges, overdentures) in the maxillary and/or mandibular arch. This is a direct therapeutic/restorative application within the body.
- Device Description: The description details a physical dental implant abutment made of titanium, designed to connect to a dental implant. This is a medical device used for structural support.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are specifically designed for diagnostic purposes.
Therefore, the Thommen SPI® VARIOmulti Angled Abutments are medical devices used for dental restoration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Thommen SPI® VARIOmulti 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 splinted crowns, bridges or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SPI® Dental Implant System. They have an internal connection to the implant and are used for multi-unit, screw-retained, prefabricated restorations. VARIOmulti Angled Abutments are made of titanium and are available in diameters from 3.5 to 4.5 mm with an angle of 30° to the implant. The system includes dedicated prosthetic components including protective and temporary caps. SPI® VARIOmulti Angled Abutments are compatible with the Nobel Biocare Multi-unit Abutment System.
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)
Fatigue testing was performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. The subject device SP1® VARIOmulti Angled Abutment was determined to have sufficient resistance to fatigue and performed comparably to the predicate device cleared under K090153.
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
510(k) Summary
SPI® VARIOmulti Angled Abutment
510(k) Summary
SPI® VARIOmulti Angled Abutment Special 510(k): Device Modification
AUG 1 9 2010
រ
July 30, 2010
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:
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® VARIOmulti Angled Abutment |
|---|---|
| Common Name: | 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 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 splinted crowns, bridges or overdentures.
1
ాన్న
DEVICE DESCRIPTION
SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SPI® Dental Implant System. They have an internal connection to the implant and are used for multi-unit, screw-retained, prefabricated restorations. VARIOmulti Angled Abutments are made of titanium and are available in diameters from 3.5 to 4.5 mm with an angle of 30° to the implant. The system includes dedicated prosthetic components including protective and temporary caps. SPI® VARIOmulti Angled Abutments are compatible with the Nobel Biocare Multi-unit Abutment System.
EQUIVALENCE TO MARKETED PRODUCT
Thommen Medical AG demonstrated that for the purposes of FDA's regulation of medical devices, SP10 VARIOmulti Angled Abutment is substantially equivalent in indications and design principles to the predicate devices, SPI® VARIOmulti Angled Abutment K090153 and SPI® VARIOmulti Abutment K072856.
The subject device has the same intended use as the predicate devices and has the same Indications for Use Statement as the predicate cleared under K090153.
The subject device has the same technological characteristics as the predicate devices. The subject and predicate devices are all fabricated from the same materials (commercially pure titanium conforming to ASTM F67) and share similar design characteristics. All are multi-unit, screw retained dental implant abutments available in diameters of 3.5 to 4.5 mm. The subject and predicate devices are packaged using the same materials and are to be sterilized by the same methods.
PERFORMANCE TESTING
Fatigue testing was performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. The subject device SP1® VARIOmulti Angled Abutment was determined to have sufficient resistance to fatigue and performed comparably to the predicate device cleared under K090153.
In summary, the SPI® VARIOmulti 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 materials, and
- · is packaged and sterilized using the same materials and processes.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized depiction of three overlapping, curved shapes, possibly representing waves or abstract figures. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Thommen Medical, AG C/O Ms. Linda K. Schulz Paxmed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
AUG 1 9 2010
Re: K101798
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: July 30, 2010 Received: August 02, 2010
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 vours.
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
Enclosure
4
510(k) Summary
SPI® VARIOmulti Angled Abutment
Indications for Use
510(k) Number (if known): K101798
SPI® VARIOmulti Angled Abutment Device Name:
Indications for Use:
Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with Thommen SPI - VARIOmunt Angled Abuthons are meetibular arch to provide support for splinted crowns, bridges or overdentures.
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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
Kain Mily for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K01798