(117 days)
Not Found
Not Found
No
The summary describes a dental implant abutment and its intended use, with no mention of AI or ML technology.
No
The device, a dental implant abutment, is intended to support crowns, bridges, or overdentures. While these supported devices could be considered therapeutic, the abutment itself generally functions as a structural component rather than directly treating or preventing a disease or condition. It facilitates a restorative procedure but isn't itself a therapeutic agent or method.
No
The device, an abutment, is for supporting crowns, bridges, or overdentures on implants. Its function is structural and restorative, not diagnostic.
No
The device description clearly states it is an "Abutment System" and describes physical components ("additional abutments to fit the 4.0 platform components"), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing support for crowns, bridges, or overdentures in the mouth, in conjunction with dental implants. This is a surgical/prosthetic application, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the design and fit of the abutment for dental implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Thommen SPI® EASY Ø 4.0 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The design of the SPI EASY Abutment System has been modified to add additional abutments to fit the 4.0 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.
SPI EASY Dental Implant 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
SPI® EASY Ø 4.0 Abutment
510(k) Summary
Thommen Medical AG Special 510(k): Device Modification
SEF 1 9 2007
SPI® EASY Ø 4.0 Abutment
ADMINISTRATIVE INFORMATION
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
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: Ischulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Name:
Product Code Classification Panel: Reviewing Branch:
SPI® EASY Ø 4.0 Abutment Dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3640), 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
The Thommen SPI® EASY Ø 4.0 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.
DEVICE DESCRIPTION
The design of the SPI EASY Abutment System has been modified to add additional abutments to fit the 4.0 platform components.
EQUIVALENCE TO MARKETED PRODUCT
The SPI EASY Ø 4.0 Abutment has the following similarities to the unmodified predicate SPI EASY Dental Implant Abutment:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged using the same materials and processes.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
SEP 1 9 2007
Re: K071453
Trade/Device Name: SPI® EASYØ 4.0 Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 22, 2007 Received: August 23, 2007
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 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 - 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); 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.
Syndie Y. Michael Davis
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
Indications for Use
Applicant:
Thommen Medical AG
510(k) Number (if known): K071453
SPI® EASY Ø 4.0 Abutment Device Name:
Indications for Use:
The Thommen SPI® EASY Ø 4.0 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.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | 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
| 510(k) Number: | 1671453 |
|---|---|
| ---------------- | --------- |
Page 14 of 131