(21 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the "PreFormance™ Temporary Cylinders" device:
This document is a 510(k) Premarket Notification for a device modification, specifically for "PreFormance Temporary Cylinders." The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way a PMA (Pre-Market Approval) or some de novo classifications might require.
Therefore, the information for many of your requested points will be "Not Applicable" or "Not Provided" because the nature of a 510(k) submission for a device modification typically focuses on showing that the modified device is as safe and effective as its predicate without the need for extensive new clinical performance studies. The "study" here refers to the comparison against the predicate device rather than a de novo clinical trial with specific performance metrics.
Acceptance Criteria and Device Performance for PreFormance™ Temporary Cylinders
Given that this is a 510(k) submission demonstrating substantial equivalence based on a modification of an existing device, the "acceptance criteria" are primarily related to material, design, and functional similarity to the predicate device, thereby inferring similar performance. Performance standards have not been established by the FDA for this type of device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Material Composition Equivalence | The PreFormance Temporary Cylinders are made of the same material (PEEK) as the predicate PreFormance Posts. |
| Intended Use Equivalence | The Indications for Use are consistent with the predicate device (accessory to endosseous dental implants to support a prosthetic device in partially/fully edentulous patients, supporting single/multiple unit prostheses for up to 180 days, non-occlusal loading). |
| Technological Characteristics Equivalence | The PreFormance Temporary Cylinders contain features and functions which are similar to the predicate PreFormance Posts. The only noted difference is a material retention feature on the cylinder body, which the predicate posts do not have. |
| Safety and Effectiveness Equivalence | Concluded to be substantially equivalent to the legally marketed predicate device (PreFormance Posts, K053170), implying comparable safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not provided. This 510(k) does not describe a clinical "test set" in the context of a performance study with human subjects. The evaluation is based on a comparison to the predicate device and potentially engineering analysis or bench testing (which is not detailed in this summary).
- Data Provenance: Not applicable / Not provided for a clinical test set. The submission is a comparison to the company's own predicate device (PreFormance Posts).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable / Not provided. Ground truth in the context of a clinical performance study with expert adjudication is not part of this 510(k) submission.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable / Not provided. No human subject test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. This type of study is not relevant to a device modification 510(k) submission that demonstrates substantial equivalence primarily through material and functional similarity to a predicate.
- Effect Size of AI Improvement: Not applicable. AI is not mentioned or implied in this device or its evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Done
- Standalone Performance Done?: No. This device is a physical dental accessory, not an algorithm or software. Its performance is inherent in its physical properties and interaction with dental implants and prosthetics.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (PreFormance Posts, K053170). The current device is compared against this known performance and characteristics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / Not provided. There is no mention of a "training set" as this is not an AI/ML device or a device requiring a clinical trial with a training phase.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable / Not provided. As there's no training set, this is not relevant. The "ground truth" for the substantial equivalence claim relies on the FDA's prior clearance of the predicate device.
{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 RiversidePalm Beach Gardens, FL 33410 |
|---|---|
| Contact | Jim BanicRegulatory Affairs SpecialistImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6932Fax. 561-514 6316Email jbanic@3implant.com |
| Date Prepared | January 20, 2006 |
| Device Name | PreFormance Temporary Cylinders |
| Classification Name | Endosseous Dental Implant |
| Device Classification | Class IIDental Devices Panel21 CFR § 872.3630 |
| Predicate Devices | PreFormance Posts -> K053170 |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. |
| Device Description | The PreFormance Temporary Cylinders will be made ofthe same material (PEEK) as the PreFormance Posts. Thetemporary cylinders have a material retention feature |
| located on the cylinder body area, whereas the posts donot have this feature on the post body. | |
| Indications for Use | The PreFormance Temporary Cylinders are intended foruse as an accessory to endosseous dental implants tosupport a prosthetic device in a partially or fullyedentulous patient. They are intended for use to supportsingle and multiple unit prostheses in the mandible ormaxilla for up to 180 days during endosseous andgingival healing, and are for non occlusal loading ofsingle and multiple unit provisional restorations. Theprostheses can be screw or cement retained to theabutment. |
| TechnologicalCharacteristics | The PreFormance Temporary Cylinders are made of thesame material and contain features and functions whichare similar to the currently available PreFormance Posts. |
| Conclusion | The PreFormance Temporary Cylinders are substantiallyequivalent to the legally marketed PreFormance Posts. |
{1}------------------------------------------------
:
{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
§ 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.)