(19 days)
Not Found
No
The 510(k) summary describes a physical dental device (temporary cylinders) made of PEEK material, with no mention of software, algorithms, or any AI/ML related terms or concepts. The description focuses on the material, dimensions, and intended use as a physical support structure.
No.
The device is described as an accessory to endosseous dental implants that supports a prosthetic device. It is not intended to directly treat a disease or condition.
No
The device is described as an accessory to dental implants used to support prosthetic devices during healing. There is no mention of it being used for diagnosis or detecting any medical condition. Its function is purely structural and supportive.
No
The device description clearly states the device is made of PEEK material and is a physical cylinder intended to be cemented onto an abutment, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Provide Temporary Cylinders are physical components intended to be implanted and used within the body to support dental prostheses. They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly describes a structural and supportive function within the oral cavity, not a diagnostic testing function.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Provide 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 cement retained to the abutment.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Provide Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The cylinder is cemented onto an abutment. An acrylic resin provisional restoration can be built onto the cylinder. The height of these cylinders will be 6.5mm and the platform diameters are 4.8 and 6.5mm. Furthermore, they will be used as single use to support a single-unit restoration and multi use where two or more cylinders are splinted together to support a provisional multi-unit restoration
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.
PreFormance Posts -> K053170
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
Summary of Safety and Effectiveness
MAY 16 2006
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 | 25 April 2006 |
| Device Name | Provide Temporary Cylinders |
| Classification Name | Endosseous Dental Implant Abutment |
| 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 Provide Temporary Cylinders will be made of the
same material (PEEK) as the PreFormance Posts. The
cylinder is cemented onto an abutment. An acrylic resin
provisional restoration can be built onto the cylinder. The
height of these cylinders will be 6.5mm and the platform
diameters are 4.8 and 6.5mm. Furthermore, they will be
used as single use to support a single-unit restoration and
multi use where two or more cylinders are splinted together
to support a provisional multi-unit restoration |
| Indications for Use | The Provide 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 cement retained to the
abutment. |
| Technological
Characteristics | The Provide Temporary Cylinders are made of the same
material and contain features and functions which are
similar to the currently available PreFormance Posts. |
| Conclusion | The Provide Temporary Cylinders are substantially
equivalent 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 is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2005
Mr. Jim Banic Regulatory Affairs Specialist 3i Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K061177
Trade/Device Name: Provide Temporary Cylinders Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 25, 2006 Received: April 27, 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 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.
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 Part 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-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,
Snytte Y. Mickue Omd.
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. Internal Innovations, Inc.
Special 510(k) Premarket Notification – Provide™ Temporary Cylinders: Device Modification
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Provide Temporary Cylinders
Indications for Use:
The Provide 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 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: ✓
(Per 21 CFR 801.109)
OR
Over the Counter Use:
Suren Runner
of Arasthesiology, General Hospital,
...n Control, Dental Devices
Numbar: Ko61177