(120 days)
No
The summary describes a CAD/CAM system for designing patient-specific dental abutments based on scans, but there is no mention of AI or ML in the device description, intended use, or performance studies. The design process appears to be based on parameters derived from the scan within the CAD/CAM software, not through AI/ML algorithms.
No
This device is an accessory to dental implants, intended to support a prosthetic device, not to treat or cure a disease or condition.
No
The device description indicates it is used to support prosthetic devices in edentulous patients, not to diagnose a condition.
No
The device description explicitly states that the device is a physical abutment manufactured from titanium alloy or ceramic, which is a hardware component. While software is used in the design process, the final device is 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 therapeutic or restorative function, not a diagnostic one.
- Device Description: The description details the design and manufacturing process of a physical dental abutment. It does not describe a test or assay performed on biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition
The device is a custom-designed medical device used in a dental procedure.
N/A
Intended Use / Indications for Use
BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended 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
Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.
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)
Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648.
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
BIOMET 3i Traditional 510(k)
Patient Specific Dental Abutments (Encode) Designed Using Cadent iTero Scanner and inLab Software v3.5
DEC 3 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
510(k) Summary
Submitter:
BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410
1038806 Establishment Reg. Number:
Contact Person:
Simeon Simone, Regulatory Affairs Specialists
Contact Phone/Fax/Email:
Tel. 561-776-6831 Fax. 561-383-3407 Email: simeon.simone@biomet.com
Date Prepared:
August 2nd , 2010
Trade/Proprietary Name:
Encode® Patient Specific Abutments
Common/Usual Name:
Classification Name:
Dental Abutment
Endosseous Dental Implant Abutment
Device Classification/Code:
872.3630
Predicate Device(s) :
BIOMET 3i - Encode® Patient Specific Dental Abutments K032263 & K052648
1
.
Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5
Device Description:
Indications for Use:
Performance Data:
Equivalence Data:
Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.
BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended 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.
Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648.
BIOMET 3i Patient-Specific Dental Abutments (Encode ) have the same intended use and indications, principles of operation, and technological characteristics as previously cleared BIOMET 3i Patient-Specific Dental Abutments. The differences in scanning and CAD/CAM processes do not raise any new questions of safety or effectiveness. Validation data demonstrates that the modified process results in a finished device that is as safe and effective as BIOMET 3i 's Patient-Specific Patient-Specific Dental Abutments that are currently cleared with previous scanner systems. Thus, the BIOMET 3i Patient-Specific Dental Abutments are substantially equivalent to its predicate devices.
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. To the right of the seal is a stylized symbol featuring three abstract shapes, possibly representing people or services, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Simeon Simone Regulatory Affairs Specialists BIOMET 31, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
DEC - 3 2010
Re: K102209
Trade/Device Name: BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v.3.5 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 19, 2010 Received: November 23, 2010
Dear Mr. Simone:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Simone
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours. .
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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 Traditional 510(k)
Patient Specific Dental Abutments (Encode®) Designed Using.Cadent iTero Scanner and inLab Software v3.5
Indications for Use
510(k) Number (if known):
Device Name:
BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v.3.5
Indications for Use:
BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device
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