(34 days)
Not Found
Not Found
No
The summary describes a physical dental implant abutment and does not mention any software, algorithms, or AI/ML terms.
No
The device is a dental implant abutment used to support crowns, bridges, or overdentures, which are restorative or prosthetic functions, not therapeutic.
No
Explanation: The device, SPI ART Abutments, is described as being used to support crowns, bridges, or overdentures, which indicates a therapeutic or restorative purpose rather than a diagnostic one. There is no mention of identifying, detecting, or assessing medical conditions.
No
The device description explicitly states that the device is a "zirconia dental implant abutment," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the SPI® ART Abutments are dental implant abutments used to support crowns, bridges, or overdentures in the mouth. They are a physical component used in a surgical and restorative procedure within the body.
There is no indication that this device is used to test or analyze biological samples outside of the body.
N/A
Intended Use / Indications for Use
SPI® ART 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.
SPI ART Abutments are contraindicated for free-end bridges with more than one intermediate pontic element.
Product codes
NHA
Device Description
Thommen SPI ART Abutments are zirconia dental implant abutments for use with the SPI Dental Implant System.
Both the SPI ART Abutment and SPI ART Grinding (Milling) Abutment have the same design as their titanium counterparts, SPIEASY abutments for cemented restoration and SPI RETAIN milling abutments. Each of the SPI ART abutment types comes in two sizes.
SPI ART abutments are made from zirconium oxide (Y-TZP) and are designed specifically for use with ceramic cemented restorations.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
SPI® ART Abutment
510(k) Summary
JUL 3 1 2006
Thommen Medical AG SPI® ART Abutment
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: Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone (858) 792-1235 Fax (858) 792-1236
DEVICE NAME
| Classification Name: | Abutment, Implant, Dental, Endosseous |
|---|---|
| Trade/Proprietary Name: | SPI® ART Abutment |
| Common Name: | Endosseous Dental Implant System Component |
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.
DEVICE CLASSIFICATION
Endosseous dental implant abutments are Class II devices (21 CFR 872.3630). The device classification is reviewed by the Dental Devices Branch. The product code for "Abutment, Implant, Dental, Endosseous" is NHA.
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2of2 K061807
SPI® ART Abutment
INDICATIONS FOR USE
SPI® ART 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.
SPI ART Abutments are contraindicated for free-end bridges with more than one intermediate pontic element.
DEVICE DESCRIPTION
Thommen SPI ART Abutments are zirconia dental implant abutments for use with the SPI Dental Implant System.
Design
Both the SPI ART Abutment and SPI ART Grinding (Milling) Abutment have the same design as their titanium counterparts, SPIEASY abutments for cemented restoration and SPI RETAIN milling abutments. Each of the SPI ART abutment types comes in two sizes.
Material
SPI ART abutments are made from zirconium oxide (Y-TZP) and are designed specifically for use with ceramic cemented restorations.
EQUIVALANCE TO MARKETED DEVICE
Thommen Medical AG has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SPI ART Abutment is 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K061807
Trade/Device Name: SPI® Art Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 23, 2006 Received: June 27, 2006
Dear Mr. Larson:
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, iisting 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.
3
Page 2 - Mr. Larson
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Signature
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
4
510(k) Premarket Notification
SPI® ART Abutment
06/807 INDICATIONS FOR USE
510(k) Number (if known):
SPI® ART Abutment Device Name:
Indications for Use:
SPI® ART 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.
SPI ART Abutments are contraindicated for free-end bridges or bridges with more than one intermediate pontic element.
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)
Kein Muller Sir HSS
Sign-Ciff) .on Siyn-Cift)
An of Anesthesiology, General Hospitalian of Anesthesion of Anesther in of Anesthestors
Number Ko. 1801
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