(59 days)
No
The summary describes a physical dental device component and does not mention any software, algorithms, or AI/ML capabilities.
No
The device provides temporary support for dental restorations and maintains gingival contour, but it does not directly treat or alleviate a disease or condition for therapeutic purposes.
No
The device description states it provides temporary support for crowns or bridges and maintains gingival contour, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is made from an acrylic-based polymer with a titanium base, indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the SPI® Customizable Gingiva Former is a temporary dental implant component used in the mouth to support crowns or bridges and maintain gingival contour. It is a physical device used directly on the patient's anatomy.
- No Sample Analysis: There is no mention of this device being used to analyze any biological samples taken from the patient.
Therefore, based on the provided information, this device falls under the category of a medical device used for surgical and restorative procedures, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
Product codes
NHA
Device Description
The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.
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)
K051527, K033346, K023645, K031747
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.)
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510(k) Summary
REVISED 510(k) Summary
Ko92248
Thommen Medical AG Special 510(k): Device Modification
SPI® Customizable Gingiva Former
SEP 2 5 2009
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: 1schulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | SPI® Customizable Gingiva Former |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Regulations: | Abutment, Implant, Dental, Endosseous |
| 21 CFR 872.3630, Class II | |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
| Establishment Registration Number: | 3003836985 |
| Owner/Operator Number: | 9051144 |
INTENDED USE
The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
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Ko92248
DEVICE DESCRIPTION
The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.
EQUIVALENCE TO MARKETED PRODUCT
Predicate devices: K051527, K033346, K023645 and K031747.
The SPI® Customizable Gingiva Former has the following similarities to the unmodified predicate devices:
- · has the same intended use,
- · uses the same operating principle,
- · uses the same or similar materials
- · incorporates the same basic design, and
- · is packaged using the same materials and processes.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 5 LUUS
Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs Specialist PaxMed Interational, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K092248
Trade/Device Name: SPI® Customizable Gingiva Former Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 17, 2009 Received: September 18, 2009
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.
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 i Register.
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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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
R. Un for
Susan Runner, D.D.S., M.A. Acting Division 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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REVISED Indications for Use
Applicant: Thommen Medical AG
510(k) Number (if known):
Device Name: SPI® Customizable Gingiva Former
Indications for Use:
The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPT® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 Muluy for MSP
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: