(9 days)
The PreFormance Abutment Posts and 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™ Abutment Posts and Temporary Cylinders will be made of the same material (PEEK) as the predicate PreFormance™ Posts and Temporary Cylinders. The posts will be available in both straight and 15° pre-angled configurations while the cylinders will be straight. The cylinders will have either a hexed or non-hexed connection. The hexed connection is for single unit prostheses while the non-hexed is for multi use. The posts and cylinders will connect to 3i's externally connected implants.
This 510(k) summary (K061969) is for a dental device, specifically "PreFormance™ Abutment Posts and Temporary Cylinders." It is a submission seeking clearance for a modified version of an already marketed device, primarily concerning the connection to the implant.
It's important to note that this document does not describe a study proving the device meets acceptance criteria. Instead, it's a 510(k) summary which details the device, its intended use, and argues for its substantial equivalence to existing predicate devices.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not present in this type of regulatory document. The FDA clearance for this device hinges on its similarity to already approved devices, not on a new, comprehensive performance study with acceptance criteria as typically understood for new major medical devices.
Here's an analysis based on the provided text, highlighting what is and isn't available:
Acceptance Criteria and Device Performance (Not directly available in this document)
This document does not specify quantitative acceptance criteria or report device performance against such criteria. The submission aims to demonstrate substantial equivalence to previously cleared devices based on similar materials, technological characteristics, and intended use, rather than presenting a de novo performance study with defined acceptance metrics.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, implying that the performance of the new device is expected to be similar to that of the predicate devices. | Not directly reported in terms of specific performance metrics. The document states, "The PreFormance™ Abutment Posts and Temporary Cylinders are substantially equivalent to the legally marketed PreFormance™ Abutment Posts and Temporary Cylinders." This implies that its performance is presumed to meet the existing standards demonstrated by the predicate devices. |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This 510(k) summary does not describe a performance study with a test set. The argument for substantial equivalence is based on design, materials, and intended use comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No specific performance test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method for the test set
- Not applicable/Not provided. No adjudication method for a test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This device is a physical dental implant accessory, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not applicable/Not provided. No performance study with a defined ground truth is presented in this document. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set or ground truth establishment for a training set is relevant for this device.
Summary of what the K061969 document does provide:
- Device Description: PreFormance™ Abutment Posts and Temporary Cylinders made of PEEK, available in straight and 15° pre-angled configurations (posts), and straight with hexed or non-hexed connections (cylinders). They connect to 3i's externally connected implants.
- Intended Use: Accessory to endosseous dental implants to support single and multiple unit prostheses in partially or fully edentulous patients, for up to 180 days during healing, for non-occlusal loading of provisional restorations.
- Technological Characteristics: Similar to predicate devices, with the sole modification being the connection to the implant (external hexed design for the modified device vs. internal connection for the predicate).
- Predicates: PreFormance™ Posts (K053170) and PreFormance™ Temporary Cylinders (K060291).
- Conclusion for Clearance: The device is "substantially equivalent" to the legally marketed predicate devices, based on similar materials, indications for use, and technological characteristics (with the noted connection modification). This "substantial equivalence" is the basis for its regulatory clearance, meaning it is deemed as safe and effective as the existing devices without requiring new extensive clinical trials to prove efficacy from scratch.
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510(k) 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 | July 3, 2006 |
| Device Name | PreFormance™ Abutment Posts and Temporary Cylinders |
| Classification Name | Endosseous Dental Implant Abutment |
| DeviceClassification | Class IIDental Devices Panel21 CFR § 872.3630 |
| PredicateDevices | PreFormance™ Posts -> K053170PreFormance™ Temporary Cylinders -> K060291 |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. |
| Device Description | The PreFormance™ Abutment Posts and Temporary Cylinders will be made of the same material (PEEK) as the predicate PreFormance™ Posts and Temporary Cylinders.The posts will be available in both straight and 15° pre-angled configurations while the cylinders will be straight.The cylinders will have either a hexed or non-hexed connection. The hexed connection is for single unit prostheses while the non-hexed is for multi use. The posts and cylinders will connect to 3i's externally connected implants. |
| Indications for Use | The PreFormance Abutment Posts and TemporaryCylinders are intended for use as an accessory toendosseous dental implants to support a prosthetic devicein a partially or fully edentulous patient. They are intendedfor use to support single and multiple unit prostheses in themandible or maxilla for up to 180 days during endosseousand gingival 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™ Abutment Posts and TemporaryCylinders have the same technological characteristics asthe currently available PreFormance™ Abutment Posts andTemporary Cylinders. The modification is solely in theconnection to the implant. The predicate device mates withthe internal connection implant design while the modifieddevice mates with the external hexed implant design. |
| Conclusion | The PreFormance™ Abutment Posts and TemporaryCylinders are substantially equivalent to the legallymarketed PreFormance™ Abutment Posts and TemporaryCylinders. |
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Kolo 1969
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and a caduceus symbol is visible in the lower part of the eagle. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2006
Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K061969
Trade/Device Name: PreFormance Posts Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 3, 2006 Received: July 12, 2006
Dear Mr. Banie:
We have reviewed vour 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 vour 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. 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 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Pari 807.97). 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-fire number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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
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Special 510(k) Premarket Notification PreFormance™ Abutment Posts and Temporary Cylinders
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PreFormance Posts
Indications for Use:
The PreFormance Abutment Posts and 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 aburment,
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)
Karl-Betz DVS (e.V.) Susann Kamke
1945
of Anesihestology, General Hospital n Control. Dental Device
ictor Kobi 1969
§ 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.)