(21 days)
Not Found
No
The summary describes a physical dental implant accessory made of PEEK and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as an accessory to dental implants to support a prosthetic device, not to treat a disease or condition itself.
No
The device is described as an accessory to dental implants to support prosthetic devices, and its intended use is to support prostheses during healing. It does not mention any function for identifying, analyzing, or monitoring medical conditions, which are characteristics of a diagnostic device.
No
The device description explicitly states the device is made of PEEK, a material, indicating it is a physical component and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to dental implants to support a prosthetic device in a patient. This is a direct interaction with the patient's body for a structural purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the material and physical features of the temporary cylinders, consistent with a medical device used in a surgical or restorative procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
Therefore, the PreFormance Temporary Cylinders fall under the category of a medical device, specifically a dental accessory, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.
Product codes
NHA
Device Description
The PreFormance Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The temporary cylinders have a material retention feature located on the cylinder body area, whereas the posts do not have this feature on the post body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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)
Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act.
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
K06029/
Implant Innovations, Inc. Informations, Inc.
Special 510(k) Premarket Notification – PreFormance™ Temporary Cylinders: Device Modification
-EB % 7 2006 Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Implant Innovations, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410 |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jim Banic
Regulatory Affairs Specialist
Implant Innovations, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-776-6932
Fax. 561-514 6316
Email jbanic@3implant.com |
| Date Prepared | January 20, 2006 |
| Device Name | PreFormance Temporary Cylinders |
| Classification Name | Endosseous Dental Implant |
| Device Classification | Class II
Dental Devices Panel
21 CFR § 872.3630 |
| Predicate Devices | PreFormance Posts -> K053170 |
| Performance | Performance standards have not been established by the
FDA under Section 514 of the Federal Food, Drug and
Cosmetic Act. |
| Device Description | The PreFormance Temporary Cylinders will be made of
the same material (PEEK) as the PreFormance Posts. The
temporary cylinders have a material retention feature |
| located on the cylinder body area, whereas the posts do
not have this feature on the post body. | |
| Indications for Use | The PreFormance Temporary Cylinders are intended for
use as an accessory to endosseous dental implants to
support a prosthetic device in a partially or fully
edentulous patient. They are intended for use to support
single and multiple unit prostheses in the mandible or
maxilla for up to 180 days during endosseous and
gingival healing, and are for non occlusal loading of
single and multiple unit provisional restorations. The
prostheses can be screw or cement retained to the
abutment. |
| Technological
Characteristics | The PreFormance Temporary Cylinders are made of the
same material and contain features and functions which
are similar to the currently available PreFormance Posts. |
| Conclusion | The PreFormance Temporary Cylinders are substantially
equivalent to the legally marketed PreFormance Posts. |
1
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2006
Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Dr. Palm Beach Gardens, Florida 33410
Re: K060291
Trade/Device Name: Performance Temporary Cylinder Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2006 Received: February 6, 2006
Dear Mr. Banic:
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 mendments, 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 (1 will), it neg of 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 - Mr. Jim Banic
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 requirence as betrenir 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), r you dontact 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 Internation 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,
Susan Runre
2 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
Implant Innovations, Inc. Inforant Innovations, the
Page 1 of 1
510(k) Number (if known): _
Device Name: PreFormance Temporary Cylinders
Indications for Use:
The PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X
(Per 21 CFR 801.109)
OR
Over the Counter Use:
Kein Haley for MSR
logy, General Hospital,
Control Dental Devices
K 060291