(9 days)
Not Found
No
The summary describes a physical dental implant accessory made of PEEK, with no mention of software, data processing, or AI/ML terms.
No.
The device is described as an "accessory to endosseous dental implants" and is intended to "support a prosthetic device," not to treat a disease or condition itself.
No
This device is an accessory to dental implants, intended to support prosthetic devices during healing. It does not perform any diagnostic function such as identifying, confirming, or monitoring a disease or condition.
No
The device description explicitly states the device is made of PEEK and describes physical components (posts and cylinders), indicating it is a hardware device, not software-only.
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 surgical/dental device used directly on or in the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing biological samples.
- Device Description: The description details the materials and configurations of the abutment posts and temporary cylinders, which are physical components used in dental procedures.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the PreFormance Abutment Posts and Temporary Cylinders fall under the category of a medical device used in a surgical/dental context, not an in vitro diagnostic device.
N/A
Intended Use / 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 abutment.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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): 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
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 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 | July 3, 2006 |
| Device Name | PreFormance™ Abutment Posts and Temporary Cylinders |
| Classification Name | Endosseous Dental Implant Abutment |
| Device
Classification | Class II
Dental Devices Panel
21 CFR § 872.3630 |
| Predicate
Devices | PreFormance™ Posts -> K053170
PreFormance™ Temporary Cylinders -> K060291 |
| 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™ 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 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™ Abutment Posts and Temporary
Cylinders have the same technological characteristics as
the currently available PreFormance™ Abutment Posts and
Temporary Cylinders. The modification is solely in the
connection to the implant. The predicate device mates with
the internal connection implant design while the modified
device mates with the external hexed implant design. |
| Conclusion | The PreFormance™ Abutment Posts and Temporary
Cylinders are substantially equivalent to the legally
marketed PreFormance™ Abutment Posts and Temporary
Cylinders. |
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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.
3
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
4
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