(93 days)
No
The document describes standard dental abutments and restorative components, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device is described as an accessory to dental implants to support a prosthetic device and to shape and maintain soft tissue. It is a structural component of a dental restoration, not something that treats or cures a disease or condition.
No
The device is described as dental abutments and restorative components used to support prosthetic devices in edentulous patients, which are components for restoration, not for diagnosing medical conditions.
No
The device description explicitly states that the device consists of "a variety of abutments, posts, cylinders and screws," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that these are dental abutments and restorative components used as accessories to dental implants to support prosthetic devices in the mouth. They are physical components used in the body, not for testing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the BIOMET 3i Dental Abutments are medical devices, but they fall under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
Restorative Components
- Temporary Healing Abutments are intended for use to shape and maintain . the soft tissue opening during healing.
- . Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dental prosthetics.
- . Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the dental implant.
Product codes
NHA
Device Description
The BIOMET 3i dental pre-formed and castable abutments and other restorative components consists of a variety of abutments, posts, cylinders and screws which are utilized to support the single and multiple tooth prostheses for either screw retained or cement retained restoration. These devices include appropriate features and dimensions to mate with BIOMET 3i dental implants cleared by K063341 and K063286 with either internal connections. The abutments may be used for single and multiple teeth.
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
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
UCLA, Gingehue, Certain Provide, Pre-Angled Abutments, Conical Abutments, Tapered Abutments, Temporary Healing Abutments, Abutment Posts, Rocket II Abutments, IOL Abutments
Reference Device(s)
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.)
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Image /page/0/Picture/2 description: The image shows the logo for Biomet 3i. The logo is in black and white and features a stylized font. The letters are blocky and geometric, with the "3i" portion of the logo being smaller and slightly offset.
510(k) SUMMARY
BIOMET 3i Dental Abutments & Restorative Components
| Submitter | BIOMET 3i , Inc.
4555 Riverside
Palm Beach Gardens, FL 33410 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Diana Taylor
Manager, Regulatory Affairs
BIOMET 3i , Inc.
4555 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-776-6857
Fax 561-776-6852 |
| Date Prepared: | September 14, 2007 |
| Name of Device: | BIOMET 3i Dental Abutments |
| Common or Usual Name | Dental Abutment |
| Classification Name | Abutment, implant, dental, endosseous |
| Classification | Class II
21 CFR 872.3630 |
| Product Code | NHA |
| Predicate Devices | UCLA
Gingehue
Certain Provide
Pre-Angled Abutments
Conical Abutments
Tapered Abutments
Temporary Healing Abutments
Abutment Posts
Rocket II Abutments
IOL Abutments DEC 2 0 2007 |
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Intended Use / Indications for Use
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.
Restorative Components:
- . Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.
- Castable restorative components are intended for use as accessories to endosseous dental . implants to aid in the fabrication of dental prosthetics.
- Screw componenets are intended for use as accessories to endosseous dental implants for . retention of screw retained abutments to the dental implant.
Technological Characteristics
The BIOMET 3i dental pre-formed and castable abutments and other restorative components consists of a variety of abutments, posts, cylinders and screws which are utilized to support the single and multiple tooth prostheses for either screw retained or cement retained restoration. These devices include appropriate features and dimensions to mate with BIOMET 3i dental implants cleared by K063341 and K063286 with either internal connections. The abutments may be used for single and multiple teeth.
Substantial Equivalence
The modified BIOMET 3i dental abutments and restorative components are equivalent to the predicate BIOMET 3i dental abutments and restorative components having the same intended uses, indications, technological characteristics, and principles of operation as the predicate device(s). The minor technological differences between the modified components and their predicate devices raise no new issues of safety or effectiveness. Thus, the modified dental abutments are substantially equivalent to their predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
Ms. Diana Taylor Manager, Regulatory Affairs BIOMET 3i. Incorporated 4555 Riverside Road Palm Beach Gardens, Florida 33410
Re: K072642
Trade/Device Name: BIOMET 3i Dental Abutments and Restorative Components Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 3, 2007 Received: December 5, 2007
Dear Ms. Taylor:
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 - Ms. Taylor
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,
Sura Quono
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
BIOMET 3i™
Indications for Use
510(k) Number (if known):
Device Name: BIOMET 3i Dental Abutments and Restorative Components
Indications for Use:
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
Restorative Components
- Temporary Healing Abutments are intended for use to shape and maintain . the soft tissue opening during healing.
- . Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dental prosthetics.
- . Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the dental implant.
[IDENTIFY WHETHER THE DEVICE IS INTENDED FOR PRESCRIPTION USE AND/OR OVER-THE-COUNTER USE.]
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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