(15 days)
Not Found
No
The 510(k) summary describes a physical dental implant system and does not mention any software, image processing, AI, ML, or related performance metrics.
No.
This device is an implantable dental prosthesis used for restorative purposes, not for treating a disease or condition.
No
Explanation: The device is a dental implant system used for support of restorations in edentulous areas, not for diagnosing conditions or diseases.
No
The device description explicitly states "The SIMPACT Endosseous Dental Implant System, Line Extension," indicating a physical implant system, not a software-only device. The intended use also describes the placement and loading of physical implants.
Based on the provided information, the Simpact Dental Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for supporting dental restorations in the jawbone. IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description refers to an "Endosseous Dental Implant System," which is a device implanted into bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Simpact Dental Implant System is a medical device, but it falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The SIMPACT Endosseous Dental Implant System, Line Extension
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): 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.
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
Koજૂરીના
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 LLC
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|----------------|-----------------------------------------------------------------------------------------|
| Contact Person | Mark Schenk
Manager QA/RA
Phone: 973-588-8932
Email: mschenk@simpactdental.com |
| Date Prepared | October 21, 2008 |
1
.
| Currently Legally Marketed Device Information | |
|---|---|
| Trade Name | SIMPACT Endosseous Dental Implant System |
| Common Name | Dental Abutments |
| Classification Name | |
| and Number | Endosseous dental implant and abutment |
| 21 CFR 872.3630 | |
| 21 CFR 872.3640 | |
| Product Code | DZE, NHA |
| Predicate Devices | SIMPACT K081226 |
| Device Description | The SIMPACT Endosseous Dental Implant System, Line |
| Extension | |
| Intended 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. |
2
.
:
·
. .
.
| Statement of
Technological
Comparison | The SIMPACT Implant System Line Extensions and the
SIMPACT Implant System (K081226) have the same
indications for use and are made of the same materials. The
only dimensional specification changes were made to the
design. | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Conclusion | The SIMPACT Implant System Line Extensions are
substantially equivalent to itself. This conclusion is based upon
the fact that this device is substantially equivalent in terms of
the intended use, the indications for use, materials, design and
principles of operation. |
3
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.
4
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
5
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
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