(27 days)
Not Found
No
The 510(k) summary describes a physical dental implant abutment made of titanium and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, a dental implant abutment, provides support for restorations rather than directly treating a disease, injury, or condition.
No
The device, Thommen SP1® Dental Implant Abutments, is described as an endosseous dental implant abutment used to support crowns, bridges, or overdentures. Its intended use is purely for structural support and restoration, not for detecting, diagnosing, or monitoring a disease or condition.
No
The device description explicitly states it is made of commercially pure grade titanium and is an endosseous dental implant abutment, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- The description of the Thommen SP1® Dental Implant Abutments clearly states their intended use is to provide support for dental restorations (crowns, bridges, overdentures) in the mouth. This is a mechanical function within the body, not an analysis of a biological sample.
The information provided focuses on the device's physical characteristics, intended use within the oral cavity, and its relationship to dental implants and restorations. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
Thommen SPI® Dental Implant 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.
Product codes
NHA
Device Description
Thommen SP1® Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges.
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)
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
.
| ADMINISTRATIVE INFORMATION | JUL 2 2003 | K031747 |
|---|---|---|
| Manufacturer Name: | Thommen Medical AG | |
| Hauptstrasse 87 | ||
| CH-4437 Waldenburg | ||
| Switzerland | ||
| Telephone +41 61 965 90 20 | ||
| FAX +41 61 965 90 21 | JUL 2 2003 | |
| Official Contact: | Orlando Antunes | |
| Representative/Consultant: | Floyd G. Larson | |
| PaxMed International | ||
| 4329 Graydon Road | ||
| San Diego, CA 92130 | ||
| Telephone (858) 792-1235 | ||
| FAX (858) 792-1236 | ||
| DEVICE NAME | ||
| Classification Name: | Abutment, Implant, Dental, Endosseous (NHA) | |
| Trade/Proprietary Name: | SPI® Dental Implant Abutments | |
| Common Name: | Endosseous Dental Implant Abutment |
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.
DEVICE CLASSIFICATION
FDA has classified endosseous dental implants as a Class III device (21 CFR 872.3640). The product code for "Abutment, Implant, Dental, Endosseous" is NHA.
CONFORMANCE WITH PERFORMANCE STANDARDS
No performance standards applicable to endosseous dental implant abutments have been established by FDA. However, CP titanium Grade 4 used to manufacture Thommen dental implant abutments meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.
1
PREDICATE DEVICE INFORMATION
The predicate devices for this modification are the HA-Ti Dental Implant System, cleared by FDA on January 4, 1991 under K901927 and SPI Easy Dental Implant Abutment (Thommen A.G.), cleared on November 13, 2002 under K023645, Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental and has renamed it the SPI® System.
PACKAGING/LABELING/PRODUCT INFORMATION
Thommen SPI® Dental Implant Abutments will be packaged and sold non-sterile. The device is not represented to be "pyroqen free. All cataloques will be amended to include the modified devices, consistent with the information shown for existing devices.
INTENDED USE
Thommen SPI® Dental Implant 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.
DEVICE DESCRIPTION
Thommen SP1® Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges.
EQUIVALENCE TO MARKETED PRODUCT
The modified SPI® Dental Implant Abutments have the following similarities to the predicate HA-Ti Dental Implant Abutment and Thommen SP1® Dental Implant 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 modified Thommen SP1® Dental Implant Abutments described in this submission are, in our opinion, substantially equivalent to the predicate 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2003
Thommen Medical, AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130
Re: K031747
Trade/Device Name: SPI Dental Implant Abutment Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: June 3, 2003 Received: June 5, 2003
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 (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 Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Suser Runre
Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Applicant: Thommen Medical AG
510(k) Number:
Device Name: SPI® Dental Implant Abutment
Indications for Use:
Thommen SP1® Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
Kein Muluy for MSR
, General Hospital. n of Anesthesiolor Infection Control. De
510(k) Number: K031741 iv