(134 days)
Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of provisional restorations. The prosthesis will be mechanically retained to the abutment system.
The Certain® BellaTek™ Provisional Abutment is a two piece temporary healing abutment that consists of a machined provisional titanium alloy (6AL-4V) post, a PEEK provisional cap, and a machined stainless steel (316L) retaining screw with gold plating.
Acceptance Criteria and Device Performance Study for Certain® BellaTek™ Provisional Abutment (K130310)
The Certain® BellaTek™ Provisional Abutment is a two-piece temporary healing abutment designed to support a single prosthesis for up to 180 days during endosseous and gingival healing, with non-occlusal loading. The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Static Bend | ISO 14801 | Pass (withstand specified static load) | Passed |
| Fatigue | ISO 14801 | Pass (withstand specified cyclic loading) | Passed |
| Snap on/off Force Testing | N/A | Adequate force for secure retention and easy removal | Passed |
| Screw Torque | N/A | Maintain specified screw torque without failure | Passed |
| Comparative Static Bend/Fatigue | ISO 14801 | Equal to or better than predicate devices | Exceeds (K060291 predicate) |
Note: The specific quantitative acceptance values for "Pass" and "Adequate" are not provided in the summary but are implied to be met for FDA clearance. The "Exceeds" performance for comparative static bend/fatigue indicates the new device performed better than at least one predicate.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for each test (Static Bend, Fatigue, Snap on/off Force, Screw Torque). The summary implies standard engineering and mechanical testing methodologies were applied, which typically involve testing multiple samples to statistical significance.
- Data Provenance: The data is derived from non-clinical (laboratory) testing conducted by the manufacturer, BIOMET 3i™. The country of origin for the data is not specified but is presumably the United States, where the manufacturer is located. The data is retrospective in the sense that it was collected and analyzed for this 510(k) submission, not as part of an ongoing prospective clinical trial.
3. Number of Experts and their Qualifications for Ground Truth
- This device clearance did not involve a human expert-based ground truth establishment for the test set. The evaluation was based on non-clinical mechanical testing.
4. Adjudication Method for the Test Set
- Not applicable, as the evaluation was based on non-clinical mechanical testing, not human-reviewed data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is a mechanical component (dental abutment), and its performance is assessed through physical testing rather than algorithmic interpretation by human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
- Not applicable. The device is a physical medical device, not an algorithm or software. Its performance is assessed through its physical characteristics and mechanical integrity.
7. Type of Ground Truth Used
- The ground truth for the device's performance was established through objective measurements and pass/fail criteria defined by recognized international standards (ISO 14801) and internal engineering specifications for mechanical properties (e.g., static bend strength, fatigue life, retention forces, screw torque).
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data.
9. How Ground Truth for Training Set Was Established
- Not applicable. As above, no training set was involved.
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510(K) SUMMARY K130310: Certain® BellaTek™ Provisional Abutment
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR §807.92
| Submitter Information | |
|---|---|
| Name | BIOMET 3i™ |
| Address | 4555 Riverside Drive Palm Beach Gardens, Florida 33410 |
| Phone number | (561) 776-6840 |
| Fax number | (561) 514-6316 |
| Establishment RegistrationNumber | 1038806 |
| Name of contact person | Jacquelyn A. Hughes, RAC |
| Date prepared | February 1, 2013 |
| Name of Device | |
| Trade or proprietary name | Certain® BellaTek™ Provisional Abutment |
| Common or usual name | Dental Abutments |
| Submission Information | |
| Classification name | Endosseous Dental Implant Abutment |
| Classification panel | Dental |
| Regulation | 21CFR §872.3630 |
| Product Code(s) | NHA |
| Legally marketed device(s) towhich equivalence is claimed | K072642 BIOMET3i™ Dental Abutments and RestorativeComponents K071551 QuickBridge® Cylinder and CapK061177 PROVIDE® Temporary Cylinder K060291PreFormance® Temporary Cylinder |
| Reason for 510(k) submission | Addition to BIOMET 3i™ abutment product line to include a twopiece temporary provisional healing abutment (cylinder and cap)that will support a single prosthesis and will incorporate theEncode® impression system. |
| Device description | The Certain® BellaTek™ Provisional Abutment is a two piecetemporary healing abutment that consists of a machinedprovisional titanium alloy (6AL-4V) post, a PEEK provisionalcap, and a machined stainless steel (316L) retaining screw withgold plating. |
| Intended use of the device | The Certain® BellaTek™ Provisional Abutment is intended for |
| use in the anterior and posterior areas of the mouth. | |
| Indications for use | Provisional Abutments are intended for use as an accessory toendosseous dental implants to support a prosthetic device in apartially or fully edentulous patient. They are intended for use tosupport a prosthesis in the mandible or maxilla for up to 180 daysduring endosseous and gingival healing, and are for non occlusalloading of provisional restorations. The prosthesis will bemechanically retained to the abutment system. |
JUN 2 1 2013
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510(K) SUMMARY K130310: Certain® BellaTek™ Provisional Abutment
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| Characteristic | New Device | K060291 | K072642 | K071551 | K061177 |
|---|---|---|---|---|---|
| Abutment Post | |||||
| Material | Titanium Alloy/ASTM F136 | Titanium Alloy /ASTM F136 andPEEK/ASTM F2026 | Titanium Alloy/ASTM F136 | Titanium Alloy/ASTM F136 | Titanium Alloy/ASTM F136 |
| SurfaceModifications | Titanium NitrideCoated Anodized | N/A | Laser markingon AbutmentPost | N/A | Anodized |
| AbutmentHeight | 5.44mmAbutment withCap 6mm | 12mm (can beprepped todesiredheight) | 3, 4, 6, 8mm | 5.8mm | 5, 6, 7, 8, 9mm |
| EmergenceProfile | 3.6mm, 4.5mm,5.5mm | 4.0, 5.0, 5.6,6.6mm | 3.8, 4.1, 5.0,5.6, 6.0, 7.5mm | 4.8mm | 4.8, 6.5mm |
| PlatformDiameter | 3.4, 4.1, 5.0mm | 3.4, 4.1, 5.0,6.0mm | 3.4, 4.1, 5.0,6.0mm | 4.8mm | 4.1, 5.0, 6.0mm |
| Collar Height | 2mm | 1.5mm | Variesdepending onsize (rangesfrom 0.25mmto 9.1mm) | 1.5mm | 1, 2, 3, 4mm |
| Design | Single unit | Single Unit/Multi-Unit | Single unit | Multi-unit | Single unit |
| Type | Abutment and capsystem | Cylinder thatcan beprepped | Abutment only | Cylinder and capsystem | Abutment andtemporarycylinder option |
| OcclusalLoading | Non-occlusal | Nonocclusal | Nonocclusal | Non-occlusal | Non-occlusal |
| Abutmentretention toimplant | Screw | Screw | Screw | N/A - part ofmulti construct | Screw |
| Connection toimplant | Internal | InternalExternal | InternalExternal | N/A - part ofmulti construct | Internal |
| Abutment Cap | |||||
| Material | Polyetheretherketone(PEEK)/ ASTMF2026 | N/A | N/A | Polyetheretherketone(PEEK)/ ASTMF2026 | Polyetheretherketone(PEEK)/ ASTM F2026 |
| Surface Finish | Internal | InternalExternal | InternalExternal | N/A - part ofmulti construct | Internal |
| Cap Height | 4.0mm | N/A | N/A | 5.1mm | 6.5mm |
| Cap MarginDiameter | 4.0mm, 4.9mm,5.9mm | N/A | N/A | 4.8mm | 4.8, 6.5mm |
| Shape | Conical | N/A | N/A | Conical | Conical |
| Retention toabutment | Snap | N/A | N/A | Snap/ cement | Cemented |
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510(K) SUMMARY K130310: Certain® BellaTek™ Provisional Abutment
| Summary of the technological characteristics of the device compared to the predicate | |||||
|---|---|---|---|---|---|
| Characteristic | New Device | K060291 | K072642 | K071551 | K061177 |
| Retention to prosthesis (crown) | Mechanical | N/A | N/A | Mechanical | Mechanical/cement |
| Performance Data | |||||
| Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence | |||||
| Performance Test Summary-New Device | |||||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |||
| Static Bend | ISO 14801 | Passed | |||
| Fatigue | ISO 14801 | Passed | |||
| Snap on/off Force Testing | Passed | ||||
| Screw Torque | Passed | ||||
| Comparative Performance Information Summary | |||||
| Characteristic | Requirement | New Device | Predicate Device | ||
| Static Bend/ Fatigue | ISO 14801 | Exceeds | K060291 | ||
| Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information | |||||
| Clinical Performance Data/Information: N/A | |||||
| Conclusions Drawn from Non-Clinical and Clinical Data | |||||
| No clinical testing was necessary for a determination of substantial equivalence. The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices. |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
June 21. 2013
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Clinical Research BIOMET 3i 4555 Riverside Drive PALM BEACH GARDENS, FL 33410
Re: K130310
Trade/Device Name: Certain® BellaTek™ Provisional Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Il Product Code: NHA Dated: May 20, 2013 Received: May 23, 2013
Dear Ms. Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
ff 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 - Ms. Hughes
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 of medical devicerelated 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Reportal?roblem/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.
Susan Runner DDS, MA
Mary S.
Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K130310
Device Name: Certain® BellaTek™ Provisional Abutment
Indications for Use:
Provisional Abutments are intended for use as an accessory to endosseous deatal implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of provisional restorations. The prosthesis will be mechanically retained to the abutment system.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steens 2013.06.21 13:27:46 -04/00
(Division Sign-Off) (Division of Anestheslotogy, General Hospital Infaction Control, Dental Devices
510(q) Number: KB0310
Indications for Use Statement: Page 1 of 1
§ 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.)