(24 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe any processes that typically involve these technologies (like image processing for design). The device is described as patient-specific based on doctor's requirements, not algorithmic analysis.
No
The device is an accessory to dental implants to support a prosthetic device and does not directly provide therapeutic treatment.
No
The device, 3i Patient-Specific Dental Abutments and Overdenture Bars, is described as an accessory to dental implants to support a prosthetic device. Its purpose is to physically support prostheses, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a physical dental abutment manufactured to match a patient, which is a hardware component.
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 structural support, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics and manufacturing process of the dental abutments and overdenture bars, which are physical components used in dental restoration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information about a person's health. This device is used in vivo (within the body) as a structural component.
N/A
Intended Use / Indications for Use
The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
Product codes
NHA
Device Description
The 3i Patient-Specific Dental Abutments are designed to match an individual patient. Since each 3i Patient-Specific Dental Abutment is manufactured to match a particular patient according to the doctor's requirements, a specific device description is not possible.
However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.
The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263].
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
OCT 2 0 2005
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 | September 20, 2005 | |
| Device Name | Patient-Specific Dental Abutments | |
| Classification Name | Dental Abutments | |
| Device
Classification | Class II
Dental Devices Panel
21 CFR § 872.3630 | |
| Predicate
Devices | 3i Patient-Specific Dental Abutments
K032263 | |
| Performance | Performance standards have not been established by the
FDA under Section 514 of the Federal Food, Drug and
Cosmetic Act. | |
| Device Description | The 3i Patient-Specific Dental Abutments are designed to
match an individual patient. Since each 3i Patient-Specific
Dental Abutment is manufactured to match a particular
patient according to the doctor's requirements, a specific | |
1
device description is not possible.
K65 2648
However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.
- The 3i Patient-Specific Dental Abutments and Overdenture Indications for Use Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
- The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263].
- Conclusion The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 31 Patient-Specific Dental Abutments.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper half of the circle.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, FLORIDA 33410
Re: K052648
Trade/Device Name: Modification to 3i Patient-Specific Dental Abutments and Overdenture Bars Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: September 20, 2005 Received: September 26, 2005
Dear Mr. Banic:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed yoursed your with 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 incersate commerce proct to traylave been reclassified in accordance with the provisions of Amendinents, or to act 1000 and Cosmetic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Orbu may, therefore, market the device, subject to the general approvin uppineation (The Act. The general controls provisions of the Act include controls providents of a 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 If your device to such additional controls. Existing major regulations affecting (1 Mr), it may of buryev to fines 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 r least oc auvrsed that 1 Dr. I termination that your device complies with other requirements mean that ITA has made a determinaregulations administered by other Federal agencies. of the Act of ally i edelar statues and rightenents, including, but not limited to: registration r ou must comply with an an e labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 067), acciity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic product radiation control provisions (Sections 531-542 of the Act); applicable, the clections proute will allow you to begin marketing your device as described 21 CFK 1000-1030. This lease will affication. The FDA finding of substantial equivalence In your Section 510(x) promaticate 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), If you desire specific advice for your are 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drisber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fer
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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Page 1 __ of 1
Indications for Use
| 510(k) Number (if known): | K052648 |
|---|---|
| Device Name: | 3i Patient Specific Abutments |
Indications for Use:
The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in The prostheses can be screw or cement retained to the the mandible or maxilla. abutment.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quorn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K050645
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