(15 days)
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.
The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.
The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
The SIMPACT Endosseous Dental Implant System, Line Extension
This document is a 510(k) summary for the SIMPACT Implant System, which is a dental implant device. It is a submission to the FDA requesting clearance to market the device.
As such, this document describes the device and asserts its substantial equivalence to a predicate device based on similar indications for use, materials, design, and principles of operation. It does not contain information about acceptance criteria, clinical studies, sample sizes, expert qualifications, or ground truth establishment in the context of device performance evaluation.
Therefore, I cannot provide the requested information from this document. It does not contain the details of a study that proves the device meets specific acceptance criteria as it would for a medical AI/software device.
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Image /page/0/Picture/2 description: The image shows the word "SIMPACT" in a bold, sans-serif font. A curved line is positioned above the letters "PAC" of the word. The text is black against a white background.
NOV - 7 2008
Special 510(k) Summary
of Safety and Effectiveness:
SIMPACT Implant System
| Submitter: | SIMPACT LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Mark SchenkManager QA/RAPhone: 973-588-8932Email: mschenk@simpactdental.com |
| Date Prepared | October 21, 2008 |
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| Currently Legally Marketed Device Information | |
|---|---|
| Trade Name | SIMPACT Endosseous Dental Implant System |
| Common Name | Dental Abutments |
| Classification Nameand Number | Endosseous dental implant and abutment21 CFR 872.363021 CFR 872.3640 |
| Product Code | DZE, NHA |
| Predicate Devices | SIMPACT K081226 |
| Device Description | The SIMPACT Endosseous Dental Implant System, LineExtension |
| Intended Use | Simpact Dental Implant System is intended for use in partiallyor fully edentulous mandibles and maxillae, in support of singleor multiple-unit restorations including; cement retained terminalor intermediate abutment support for fixed bridgework.The Simpact implant is a threaded/tapered internal connectionimplant. The Simpact implant is intended for immediateplacement, where immediate implant placement is defined bythe International Congress of Oral Implantologists (ICOI) as theplacement of an implant at the time of tooth extraction, into theextraction socket.The Simpact implant is intended for immediateprovisional loading when primary stability and proper occlusionare present. Immediate Provisionalization is defined by theInternational Congress of Oral Implantologists (ICOI) as aclinical protocol for the placement of an interim prosthesiswith occlusal contact with the opposing dentition, at the sameclinical visit of implant placement. The Simpact implant can berestored with a temporary prosthesis in single tooth and multipletooth applications. |
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| Statement ofTechnologicalComparison | The SIMPACT Implant System Line Extensions and theSIMPACT Implant System (K081226) have the sameindications for use and are made of the same materials. Theonly dimensional specification changes were made to thedesign. | |
|---|---|---|
| Conclusion | The SIMPACT Implant System Line Extensions aresubstantially equivalent to itself. This conclusion is based uponthe fact that this device is substantially equivalent in terms ofthe intended use, the indications for use, materials, design andprinciples of operation. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem is a symbol of a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Mr. Mark Schenk Manager of Quality Assurance/ Regulatory Affairs Simpact LLC 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K083141
Trade/Device Name: SIMPACT Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: October 22, 2008 Received: October 23, 2008
Dear Mr. Schenk:
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. Schenk
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 vours.
Sudie H. Dickinson MD
FOR DR. CHILL LIN Chiu S. Lin. Ph. D 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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Indications for Use
510(k) Number K081226
Device Name:
SIMPACT Endosseous Dental Implant
Indications for Use:
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.
The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.
The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rupper
(Division Sign-Off) (Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: Y083741
Page 1 of 1
§ 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.)