(240 days)
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a dental implant system used to restore masticatory function, which is a therapeutic purpose.
No
Explanation: The device description states that the SwissPlant Dental Implant system consists of implants, abutments, healing components, fixation screws, and surgical armamentaria, which are all components used in a surgical procedure to restore normal masticatory function. There is no mention of the device being used to identify or diagnose a condition.
No
The device description explicitly lists physical components like implants, abutments, healing components, fixation screws, and surgical armamentaria, indicating it is a hardware-based medical device system.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a dental implant system used for surgical procedures and supporting dental restorations within the mouth (mandibles and maxillae). It is a physical implant placed in the body, not a device used to test samples from the body.
The description focuses on the surgical placement and functional use of the implant within the patient's mouth, which is characteristic of a surgical/restorative medical device, not an IVD.
N/A
Intended Use / Indications for Use
The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.
Product codes
DZE, NHA
Device Description
The SwissPlant Dental implant system consists of implants, abutments, healing components, fixation screws and surgical armamentaria for use in one or two-stage placement and restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
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
Image /page/0/Picture/0 description: The image shows the logo for Implant Direct LLC. The logo features a large letter "D" with a small circle containing a bolt at the top left. To the right of the "D" is the text "Implant Direct LLC" in a sans-serif font. Below the "D" is the website address "www.implantdirect.com".
JAN 1 4 2009
Swiss Plant Dental Implant System Traditional 510(K) Submission
510(K) Summary (21CFR 807.92(a))
- Submitter's Information Company Name: Implant Direct LLC Address: 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Telephone Number: 818-444-3300 Fax Number: 818-444-3400 Registration Number: 3001617766 Contact Person: Tom Gottenbos Date Summary Prepared: April 18, 2008 Classification Name: Implant, Dental, Endosseous Common/Usual Name: Endosseous Dental Implant
- Device Trade Name: Swiss Plant Dental Implant System 2.
- Predicate Device(s): Sulzer Dental SwissPlus Implant System (K011245), 3.
4. Device Description:
The SwissPlant Dental implant system consists of implants, abutments, healing components, fixation screws and surgical armamentaria for use in one or twostage placement and restorations.
ട്. Intended Use:
The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.
Device Comparison: 6.
This submission is comprised of devices whose physical dimensions, material composition, indications for use and methods of manufacture were previously approved and have the same principles of operation as the cited predicate devices. The differences between the components included in this submission and their predicate devise pose no new or additional issues of safety or effectiveness.
7 030 Malibu Hills Road Calabasas Hills CA USA 9 130 1 .8 18 .4 4 .3 17
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2009
Mr. Thomas Gottenbos Vice President Implant Direct LLC 27030 Malibu Hills Road Calabasas Hills, California 91301
Re: K081396
Trade/Device Name: SwissPlant Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 22, 2008 Received: December 29, 2008
Dear Mr. Gottenbos:
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.
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Page 2 - Mr. Gottenbos
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 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 premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Anthony D. Watson for
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KO81396
Device Name: SwissPlant Dental Implant System
Indications for Use:
The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully lwo-stage surgiour prosourcexillae, in support of single or multiple-unit edentations including: cement retained, screw retained or overdenture restorations including: ochion return return in support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and The Owlssi lant dental implants nultiple tooth applications recognizing initial function on single tooth and of makiple to restore normal masticatory function.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K081399 |
|---|---|
| ---------------- | --------- |
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