(185 days)
Empty
No
The document does not mention AI, ML, or any related technologies. The device description focuses on mechanical design and compatibility.
No
The device is described as an accessory to endosseous dental implants to support a prosthetic device and its function is to interface with implants and support prostheses, not to provide therapy.
No
This device, a dental abutment, is an accessory used to support a prosthetic device in edentulous patients. Its function is structural (supporting a prosthesis) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly indicates a physical dental abutment, which is a hardware component. While there is mention of design input from dental laboratories, the core device is a physical implant accessory, not software.
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 use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of the abutment in supporting a prosthesis.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection can be compared to current Encode Patient Specific abutments. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Replace HA Coated Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient. Maximum angulation for the abutment is limited to 15°.
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 testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Performance testing was based on a comparison between proposed and predicate implant/abutment systems. The results were equal or better than established acceptance criteria, where predicate testing was used as a baseline. Compatibility testing for the abutment will be performed every 6 months.
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.)
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BIOMET 31, Traditional 510(k) Premarket Notification - BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection
BIOMET 3i
SEP - 1 2011
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter: | BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1038806 |
| Contact: | Jose E. Cabrera
Sr. Manager, Regulatory Affairs
BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Tel. 561-776-6840
Fax. 561-514 6316
Email jose.cabrera@biomet.com |
| Date Prepared: | 08/27/2011 |
| Trade/Proprietary Name: | Encode Patient Specific Abutment with Nobel Replace Connection |
| Common/Usual Name: | Dental Implant Abutment |
| Classification Name: | Abutment, implant, dental, endosseous |
| Device Classification/ Code: | Class II 21 CFR §872.3630 / NHA |
| Predicate Device: | K020646, Nobel Replace HA Coated Implant
K053654, Atlantis Abutment for Nobel Replace Interface
K023113, Replace TiUnite Endosseous Implant |
| Performance Testing: | Performance testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental |
1
BIOMET 3i,
Traditional 510(k) Premarket Notification – BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection
:
:
| Abutments. Performance testing was based on a
comparison between proposed and predicat
implant/abutment systems. The results were equal o
better than established acceptance criteria, wher
predicate testing was used as a baseline. Compatibilit
testing for the abutment will be performed every 6
| months. | |
|---|---|
| Device Description: | BIOMET 3i Encode Patient Specific Abutment for |
| Nobel Replace Connection can be compared to current | |
| Encode Patient Specific abutments. The change to this | |
| device is only to the connection that is intended to | |
| interface which is identical to the interface found on the | |
| Nobel Replace HA Coated Implant. This feature does | |
| not modify the intended functionality of the | |
| implant/abutment system. This device is also intended | |
| for dental laboratories to provide limited design input to | |
| match the anatomical requirements of the patient. | |
| Maximum angulation for the abutment is limited to 15°. | |
| Indications for Use: | BIOMET 3i Dental Abutments are intended for use as |
| accessories to endosseous dental implants 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. | |
| Technological | |
| Characteristics | BIOMET 3i Encode Patient Specific Abutment for |
| Nobel Replace Connection is milled from titanium | |
| alloy, is attached to a dental implant and is indicated for | |
| the same intended use as the predicated devices | |
| reference within this pre-market notification. | |
| Conclusion: | BIOMET 3i Encode Patient Specific Abutment for |
| Nobel Replace Connection is substantially equivalent to | |
| the legally marketed predicates |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jose E. Cabrera Senior Regulatory Affairs Manager BIOMET 3i. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
SEP - 1 2011
Re: K110565
Trade/Device Name: BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 29, 2011 Received: August 31, 2011
Dear Mr. Cabrera:
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. Cabrera
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 l'ederal 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 (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.
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/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
hh 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
Indications for Use
510(k) Number (if known): KIlO565
Device Name: BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection
Indications for Use: BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants 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.
| Prescription Use X
(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)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K110565 |
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