(181 days)
Not Found
No
The summary describes a dental abutment with a specific connection type and mentions limited design input from dental laboratories, but there is no mention of AI or ML technology being used in the device itself or its design process.
No.
Explanation: The device is an accessory to a dental implant, intended to support a prosthetic device. It is not directly involved in treating or mitigating a disease or condition.
No
This device, a dental abutment, is intended to support a prosthetic device, not to diagnose a condition or disease. Its function is structural and restorative.
No
The device description clearly states it is a dental abutment, which is a physical component used in dental implants. The performance studies also describe bench testing related to mechanical properties, further indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support a prosthetic device in a patient, which is a direct clinical application within the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a dental abutment, a physical component that connects a dental implant to a prosthesis. This is a mechanical device, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly a medical device used in vivo (within the body) for dental restoration.
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
NHA
Device Description
BIOMET 3i Encode Patient Specific Abutment for Nobel Active Connection can be compared to current Encode Patient Specific Abutment for Straumann Bone level Connection. 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 Active Internal Connection 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.
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)
BIOMET 31 has conducted Design Verification Testing according to ISO 14801:2007 "Dentistry -- Dynamic Fatigue Test for Endosseous Dental Implants" on the Encode Patient Specific Abutment for Nobel Active Connection under this submission. All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 31 designs commercially in the marketplace. Performance testing data indicates that changes to the predicate device are safe and effective for its intended use and it demonstrate to be substantially equivalent. Bench Testing conducted outlined in the FDA Guidance referenced above demonstrates that the proposed device meets the mechanical properties recommendations by FDA.
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
SEP 11 2012
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 Reg. 1038806 Number:
Prepared By: Mayank Choudhary Regulatory Affairs Specialist BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 Tel. 561-776-6831 Fax. 561-514 6316 Email mayank.choudhary@BIOMET.com
Jacquelyn Hughes Contact for Questions/Review: Director Clinical and Regulatory Affairs BIOMET 3! 4555 Riverside Drive Palm Beach Gardens, FL 33410 Tel. 561-776-6700 Fax. 561-514 6316 Email jacquelyn.hughes@BIOMET.com
Encode Patient Specific Abutment for Nobel Active Connection Trade/Proprietary Name:
Common/Usual Dental Implant Abutment Name:
Classification Abutment, implant, dental, endosseous/ Dental Panel Name/ FDA Reviewing Branch:
Device Class II - 21 CFR $872.3630 / NHA Classification/Code:
K112730 - Encode Patient Specific Abutment for Straumann Bone Level Connection Predicate Device K071370 - Nobel Active Internal Connection Implant Manufacturer:
1
Purpose of the SPECIAL 510(k) notice:
The reason for this Special 510k submission is to request clearance for a modification to a device that has been cleared under the 510(k) process referred to herein as Encode Patient Specific Abutment for Nobel Active Connection. Dental Implant Abutment are referenced under 21 CFR §872.3630 and are considered Class II devices.
Device Description: BIOMET 3i Encode Patient Specific Abutment for Nobel Active Connection can be compared to current Encode Patient Specific Abutment for Straumann Bone level Connection. 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 Active Internal Connection 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.
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.
| Bellatek™ Patient Specific Abutment (EDA and EDAX) | ||
|---|---|---|
| Manufacturer | Implant | Platform (mm) |
| Biomet 3i | Biomet3i Certain Osseotite, Nanotite | 3.4 |
| 4.1 | ||
| 5 | ||
| 6 | ||
| Biomet 3i | Biomet3i Ex-Hex Osseotite, Nanotite | 3.4 |
| 4.1 | ||
| 5 | ||
| 6 | ||
| Nobel Biocare | Internal Connection Nobel Replace Implant | 3.5 |
| 4.3 | ||
| 5 | ||
| 6 | ||
| Internal Connection Nobel Active Implant | 3.5 |
2
| 4.3 | ||
|---|---|---|
| 5.0 | ||
| 3.3 | ||
| Straumann | Nobel Active Implant | 4.1 |
| 4.8 |
Technological Characteristics: The predicates and Encode Patient Specific Abutment for Nobel Active Connection have a number of very similar and equivalent design/ technological characteristics, as follows:
| Element of
Comparison | Proposed BIOMET 3i Patient
Specific Abutment for Nobel
Active Connection | Predicate OEM Nobel Active Internal
Connection Implants | Predicate Encode Patient
Specific Abutments for
Straumann Bone Level |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K071370 | K112730 |
| Indications | The 3i Patient-Specific Dental
Abutment is intended for use as
an accessory to an endosseous
dental implant to support a
prosthetic device in a partially
or edentulous patient. It is
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. | Nobel Biocare's NobelActive implants
are endosseous implant intended to
be surgically placed in the bone of the
upper or lower jaw arches to provide
support for prosthetic devices, such
as an artificial tooth, in order to
restore patient esthetics and chewing
function. Nobel Biocare's NobelActive
implants are indicated for single or
multiple unit restorations in splinted
or non-splinted applications. Nobel
Biocare's NobelActive implants may
be placed immediately and put into
immediate function provided that
initial stability requirements detailed
in the manual are satisfied. | The 3i Patient-Specific
Dental Abutment is
intended for use as an
accessory to an
endosseous dental
implant to support a
prosthetic device in a
partially or edentulous
patient. It is 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. |
| Mating
Connection | Anti-rotational, internal
engagement feature
compatible with Nobel Active
Implants | Anti-rotational, internal engagement
feature for Nobel Active Internal
Connection Implants | Anti-rotational, internal
engagement feature
compatible with
Straumann Bone Level |
| Statistical
tolerance
analysis | Yes | OEM confidential data | Yes |
3
| Compatible
| Platforms | 3.5mm, 4.3mm, 5.0mm | 3.5mm, 4.3mm, 5.0mm | 3.3m, 4.1mm, 4.8mm |
|---|---|---|---|
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Biocompatible | Yes | Yes | Yes |
| Screw Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
Performance Data: BIOMET 31 has conducted Design Verification Testing according to ISO 14801:2007 "Dentistry -- Dynamic Fatigue Test for Endosseous Dental Implants" on the Encode Patient Specific Abutment for Nobel Active Connection under this submission. All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 31 designs commercially in the marketplace. Performance testing data indicates that changes to the predicate device are safe and effective for its intended use and it demonstrate to be substantially equivalent. Bench Testing conducted outlined in the FDA Guidance referenced above demonstrates that the proposed device meets the mechanical properties recommendations by FDA.
N/A Clinical Data:
The following FDA Guidance Document for this type of product was utilized in this Performance submission: "Guidance for Industry and FDA Staff: - Special Controls Class II -Standards: Root Form Endosseous Dental Abutment/ Implant". Also, Testing was conducted following ISO standard 14801:2007 Dentistry -- Implants - "Dynamic fatigue test for endosseous dental implants". The test articles met all predetermined acceptance criteria.
Substantial The Encode Patient Specific Abutment for Nobel Replace Connection included in this submission have the same intended use, indications for use, technological Equivalence: characteristics, and principles of operation as previously cleared Encode Patient Specific abutment for Straumann Bone Level connection per the 510(k) number referenced in the Predicate Devices section above.
· Refer to the following substantial equivalence data table:
| Element of
Comparison | Proposed BIOMET 3i Patient
Specific Abutment for Nobel
Active Connection | Predicate OEM Nobel Active
Implants | Predicate Encode Patient
Specific Abutments for
Straumann Bone Level |
|--------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 510(k) Number | TBD | K071370 | K112730 |
| Indications | The 3i Patient-Specific Dental
Abutment is intended for use as | Nobel Biocare's NobelActive implants
are endosseous implant intended to | The 3i Patient-Specific
Dental Abutment is |
3/13/2012
4
| an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is 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. | be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. | intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is 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. | |
|---|---|---|---|
| Mating | |||
| Connection | Anti-rotational, internal engagement feature compatible with Nobel Active Implants | Anti-rotational, internal engagement feature for Nobel Active Internal Connection Implants | Anti-rotational, internal engagement feature compatible with Straumann Bone Level |
| Statistical | |||
| tolerance | |||
| analysis | Yes | OEM confidential data | Yes |
| Compatible | |||
| Platforms | 3.5mm, 4.3mm, 5.0mm | 3.5mm, 4.3mm, 5.0mm | 3.3mm, 4.1mm, 4.8mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Biocompatible | Yes | Yes | Yes |
| Screw Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
Conclusion: Encode Patient Specific Abutment for Nobel Active Connection and predicate designs have the same intended use, indications for use, similar technological characteristics, and principles of operation. The major technological difference between the Encode Patient Specific Abutment for Nobel Active Connection and its predicates is:
The change is only to the connection that is intended to interface which is identical to the interface found on the Nobel Active Internal Connection Implant.
The information demonstrates that the proposed device is substantially equivalent to the predicate device.
5
Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle. The eagle is facing to the right and has its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 11 2012
Biomet 3i Ms. Tamara West Senior Regulatory Affairs Specialist 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K120776
Trade/Device Name: Encode Patient Specific Abutment for Nobel Active Connection Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 13, 2012 Received: August 15, 2012
Dear Ms. West:
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.
6
Page 2- Ms. West
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 (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/Industry/default.htm.
Sincerely yours,
Wh 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
7
Indications for Use .
.
510(k) Number (if known): K120776
Device Name: Encode Patient Specific Abutment for Nobel Active 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 edentylous 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.
| Bellatek™ Patient Specific Abutment (EDA and EDAX) | ||
|---|---|---|
| Manufacturer | Implant | Platform (mm) |
| Biomet 3i | Biomet3i Certain Osseotite, Nanotite | 3.4 |
| 4.1 | ||
| 5 | ||
| 6 | ||
| Biomet 3i | Biomet3i Ex-Hex Osseotite, Nanotite | 3.4 |
| 4.1 | ||
| 5 | ||
| 6 | ||
| Nobel Biocare | Internal Connection Nobel Replace Implant | 3.5 |
| 4.3 | ||
| 5 | ||
| 6 | ||
| Nobel Biocare | Internal Connection Nobel Active Implant | 3.5 |
| 4.3 | ||
| 5.0 |
8
| Straumann | Nobel Active Implant | 3.3 |
|---|---|---|
| 4.1 | ||
| 4.8 |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Ov er-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Sheether Control Dental Devices Division of Anesthesions .
Infection Control, Dental Devices
510(k) Number: