(28 days)
unmodified predicate SPI ART Abutment
Not Found
No
The summary describes a dental abutment and its intended use, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is an abutment for dental implants, used to support crowns, bridges, or overdentures. Its function is structural and restorative, not therapeutic.
No
The device, SPI® ART Abutment, is intended to "provide support for crowns, bridges or overdentures" in conjunction with dental implants. Its function is structural support for prosthetics, not to diagnose a disease or condition.
No
The device description clearly states it is an "Abutment System," which is a physical component used in dental implants. There is no mention of software as the primary or sole 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 device is used in conjunction with dental implants to provide support for crowns, bridges or overdentures. This describes a device used in vivo (within the body) for structural support in dental restorations.
- Device Description: The description focuses on the physical design and compatibility with dental implant platforms.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on biological samples to gain information about a person's health status. This device is a physical component used in dental surgery and restoration.
N/A
Intended Use / Indications for Use
SPI® ART Abutment is 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 Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The design of the SPI ART Abutment System has been modified to add additional abutments to fit the 3.5 mm and 4.0 mm platform 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
unmodified predicate SPI ART Abutment
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
0(k) Summary
SPI® ART Abutment
510(k) Summary
Thommen Medical AG Special 510(k): Device Modification
SPI® ART Abutment
ADMINISTRATIVE INFORMATION
DEC 0 5 2007
Manufacturer Name:
Thommen Medical AG Haupstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21
Official Contact:
Representative/Consultant:
Orlando Antunes
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: flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Name:
Product Code: Classification Panel: Reviewing Branch:
SPI® ART Abutment Dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3630), Class II NHA Dental Products Dental Devices
ESTABLISHMENT REGISTRATION
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.
1
510(k) Summary
INTENDED USE
SPI® ART Abutment is 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 Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.
DEVICE DESCRIPTION
The design of the SPI ART Abutment System has been modified to add additional abutments to fit the 3.5 mm and 4.0 mm platform components.
EQUIVALENCE TO MARKETED PRODUCT
The SPI ART Ø 3.5 mm and 4.0 mm abutments have the following similarities to the unmodified predicate SPI ART Abutment:
- · have the same intended use,
- · use the same operating principle,
- · incorporate the same basic design,
- · incorporate the same materials, and
- · are packaged using the same materials and processes.
In summary, the SPI ART Abutment described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2007
Thommen Medical, AG C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K073141
Trade/Device Name: SP1® ART Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 6, 2007 Received: November 7, 2007
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, 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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snytte y. Michie O ins.
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
pecial 510(k): Device Modification
SPI® ART Abutment
Indications for Use
510(k) Number (if known):
Device Name:
SPI® ART Abutment
Indications for Use:
SPI® ART Abutment is intended to be used in conjunction with SP10 System dental implants in SP1 ART Abulinent is meetica to 60 assume in to provide support for crowns, bridges or overdentures.
SPI ART Abutment is contraindicated for free-end bridges with more than one intermediate pontic element.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (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)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
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