(115 days)
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 or cement retained to the abutment. For compatibility of BellatekTM Patient Specific Abutments, please refer to the Table below.
BIOMET 3i Encode Patient Specific Abutment for Straumann Bone Level Connection can be compared to current Encode Patient Specific Abutment for Nobel Replace 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 STRAUMANN bone level Implant. This feature does not modify the intended functionality of the Implant. implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient.
Here's an analysis of the acceptance criteria and study findings for the "Encode Patient Specific Abutment for Straumann Bone Level Connection", based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Integrity (Dynamic Fatigue) | Meets ISO 14801:2007 "Dentistry - Dynamic Fatigue Test for Endosseous Dental Implants" standards, including worst-case scenarios (30° pre-angled abutments). | All testing conducted met the acceptance criteria. Performance testing data indicates substantial equivalence to the predicate device. |
| Material | Ti-6Al-4V ELI (for both abutment and screw) | Ti-6Al-4V ELI |
| Biocompatibility | Biocompatible | Yes |
| Statistical Tolerance Analysis | Successful statistical tolerance analysis | Yes |
| Intended Use | Same as predicate device | Same as predicate device |
| Indications for Use | Same as predicate device | Same as predicate device |
| Technological Characteristics | Similar to predicate device, with primary difference only in the mating connection. | Similar to predicate device, with primary difference only in the mating connection compatible with Straumann Bone Level Implant. |
| Principles of Operation | Same as predicate device | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific number of units or samples used for the "Design Verification Testing" according to ISO 14801:2007. It only mentions that testing was conducted.
- Data Provenance: The data is a result of prospective bench testing conducted by the manufacturer, BIOMET 3i. There is no indication of country of origin for the data provided, but the submitter is based in Palm Beach Gardens, FL, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This evaluation is based on bench testing (mechanical performance), not clinical data or expert interpretation of patient data. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy for the test set is not applicable here. The "ground truth" for mechanical testing is adherence to the specified ISO standard and FDA guidance.
4. Adjudication Method for the Test Set
- Not applicable. As this is a bench test for mechanical performance, there is no adjudication method by experts for a test set in the way it would apply to clinical or imaging studies. The evaluation is based on objective measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical Data: N/A". This is a premarket notification focused on demonstrating substantial equivalence primarily through technical and performance characteristics (bench testing) to a predicate device, rather than a study involving human readers and clinical outcomes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm performance study was not done. This device is a physical dental abutment, not an AI algorithm or software.
7. Type of Ground Truth Used
- The "ground truth" for the performance study (Design Verification Testing) was based on compliance with established mechanical testing standards and guidance:
- ISO 14801:2007 "Dentistry - Dynamic Fatigue Test for Endosseous Dental Implants"
- FDA Guidance Document: "Guidance for Industry and FDA Staff: - Special Controls Class II -Standards: Root Form Endosseous Dental Abutment/ Implant"
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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JAN 1 3 2012 11112730
BIOMET 3/
Special 510(k) Premarket Notification - Encode Patient Specific Abutment for Straumann Bone Level Connection
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 3 i4555 Riverside DrivePalm Beach Gardens, FL 33410 |
|---|---|
| Establishment Reg.Number: | 1038806 |
| Contact: | Mayank ChoudharyRegulatory Affairs SpecialistBIOMET 3 i4555 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-776-6831Fax. 561-514 6316Email mayank.choudhary@BIOMET.com |
| Date Prepared: | December 15, 2011 |
| Trade/ProprietaryName:Common/UsualName:ClassificationName/ FDAReviewing Branch: | Encode Patient Specific Abutment for Straumann Bone Level ConnectionDental Implant AbutmentAbutment, implant, dental, endosseous/ Dental Panel |
| DeviceClassification/Code:Predicate DeviceManufacturer: | Class II - 21 CFR §872.3630 / NHAK110565 - Encode Patient Specific Abutment for Nobel Replace Connection |
Device Description: BIOMET 3i Encode Patient Specific Abutment for Straumann Bone Level Connection can be compared to current Encode Patient Specific Abutment for Nobel Replace 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 STRAUMANN bone level
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Image /page/1/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K112730". The characters are written in a cursive style, with some connections between the numbers.
BIOMET 3i Special 510(k) Premarket Notification – Encode Patient Specific Abutment for Straumann Bone Level Connection
This feature does not modify the intended functionality of the Implant. implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient.
- BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental Indications for Use: 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 or cement retained to the abutment. For compatibility of BellatekTM Patient Specific Abutments, please refer to the Table below.
| 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 | ||
| Straumann | Straumann Bone Level Implant | 3.3 |
| 4.1 | ||
| 4.8 |
Compatibility Chart for Patient Specific Abutments
Technological Characteristics :
The predicates and Encode Patient Specific Abutment for Straumann Bone Level Connection have a number of very similar and equivalent design / technological characteristics, as follows:
| Element of Comparison | Proposed BIOMET 3I PatientSpecific Abutment forStraumann Connection | Predicate Encode PatientSpecific Abutments for NobelReplace |
|---|---|---|
| ----------------------- | ----------------------------------------------------------------------------- | --------------------------------------------------------------------- |
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Image /page/2/Picture/0 description: The image contains a sequence of handwritten characters, seemingly a combination of letters and numbers. The sequence starts with the letter 'K', followed by the numbers '112730'. The handwriting style appears casual, with some characters slightly distorted or connected.
BIOMET 3i
Special 510(k) Premarket Notification – Encode Patient Specific Abutment for Straumann Bone Level Connection
| Indications | The 3i Patient-Specific DentalAbutment is intended for useas an accessory to anendosseous dental implant tosupport a prosthetic device ina partially or edentulouspatient. It is intended for useto support single and multipletooth prostheses, in themandible or maxilla. Theprostheses can be screw orcement retained to theabutment. | The 3i Patient-Specific DentalAbutment is intended for useas an accessory to anendosseous dental implant tosupport a prosthetic device ina partially or edentulouspatient. It is intended for useto support single and multipletooth prostheses, in themandible or maxilla. Theprostheses can be screw orcement retained to theabutment. |
|---|---|---|
| MatingConnection | Anti-rotational, internalengagement featurecompatible with StraumannBone Level | Nobel Replace anti-rotational,internal engagement featurecompatible with NobelReplace |
| Statistical tolerance analysis | Yes | Yes |
| Compatible Platforms | 3.3mm, 4.1mm, 4.8mm | 3.5mm, 4.3mm, 5.0mm,6.0mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Biocompatible | Yes | Yes |
| Screw Material | 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 Straumann Bone Level 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 3i designs commercially in the marketplace. Performance testing data indicates that the subject device demonstrate substantial equivalence to the predicate device. Bench Testing conducted outlined in the FDA Guidance referenced above demonstrates that the proposed device meets the mechanical properties recommendations by FDA.
Clinical Data: N/A
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 Straumann Bone Level Connection included in this submission have the same intended use, indications for use, Equivalence: technological characteristics, and principles of operation as previously cleared Encode Patient Specific abutment for Nobel replace connection per the 510(k) number referenced in the Predicate Devices section above.
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| Element of Comparison | Proposed BIOMET 3i Patient Specific Abutment for Straumann Connection | Predicate Encode Patient Specific Abutments for Nobel Replace |
|---|---|---|
| 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. | 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 Straumann Bone Level | Nobel Replace anti-rotational, internal engagement feature compatible with Nobel Replace |
| Statistical tolerance analysis | Yes | Yes |
| Compatible Platforms | 3.3mm ,4.1mm, 4.8mm | 3.5mm , 4.3mm, 5.0mm, 6.0mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Biocompatible | Yes | Yes |
| Screw Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
Refer to the following substantial equivalence data table:
Conclusion:
Encode Patient Specific Abutment for Straumann Bone Level 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 Straumann Bone Level 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 Straumann bone level Implant.
The information demonstrates that the proposed device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Mayank Choudhary Regulatory Affairs Specialist BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410
JAN 1 3 2012
Re: K112730
Trade/Device Name: Encode Patient Specific Abutment for Straumann Bone Level Connection Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 15, 2011 Received: January 5, 2012
Dear Mr. Choudhary:
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.
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Page 2 - Mr. Choudhary
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,
hr foc
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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Encode Patient Specific Abutment for Straumann Bone Level 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 or cement retained to the abutment. For compatibility of Bellatek™ Patient Specific Abutments, please refer to the Table below.
Compatibility Chart for Patient Specific Abutments
| Bellatek TM 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 NobelReplace Implant | 3.5 |
| 4.3 | ||
| 5 | ||
| 6 | ||
| Straumann | Straumann Bone Level Implant | 3.3 |
| 4.1 | ||
| 4.8 |
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BIOMET 3/ Special 510(k) Premarket Notification – Encode Patient Specific Abutment for Straumann Bone Level Connection
Prescription Use X
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Purner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _
0730
§ 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.)