(134 days)
No
The summary describes a mechanical dental abutment and its performance in standard mechanical tests. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved.
No.
The device is an accessory to dental implants used to support a prosthetic device, which is not a therapeutic function itself but rather a temporary structural support.
No
The device is a provisional abutment for dental implants designed to support a prosthetic device during healing, not to diagnose a condition.
No
The device description explicitly states it is a two-piece temporary healing abutment consisting of machined titanium alloy, PEEK, and stainless steel components, indicating it is a physical medical device, 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 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." This describes a device used in vivo (within the body) to support a physical structure.
- Device Description: The description details the physical components of the abutment (titanium post, PEEK cap, stainless steel screw). These are physical components for implantation and support, not reagents or instruments used to examine specimens in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to perform tests on biological samples in vitro. This device is a physical implant component used in vivo.
N/A
Intended Use / Indications for Use
The Certain® BellaTek™ Provisional Abutment is intended for use in the anterior and posterior areas of the mouth.
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.
Product codes
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior areas of the mouth, 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 Test Summary-New Device:
- Static Bend: Passed (ISO 14801)
- Fatigue: Passed (ISO 14801)
- Snap on/off Force Testing: Passed
- Screw Torque: Passed
Comparative Performance Information Summary:
- Static Bend/ Fatigue: Exceeds (ISO 14801) compared to Predicate Device K060291
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072642, K071551, K061177, K060291
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
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 Registration | |
| Number | 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) to | |
| which equivalence is claimed | K072642 BIOMET3i™ Dental Abutments and Restorative |
| Components K071551 QuickBridge® Cylinder and Cap | |
| K061177 PROVIDE® Temporary Cylinder K060291 | |
| PreFormance® Temporary Cylinder | |
| Reason for 510(k) submission | Addition to BIOMET 3i™ abutment product line to include a two |
| piece temporary provisional healing abutment (cylinder and cap) | |
| that will support a single prosthesis and will incorporate the | |
| Encode® impression system. | |
| Device description | 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. | |
| 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 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. |
JUN 2 1 2013
.
1
510(K) SUMMARY K130310: Certain® BellaTek™ Provisional Abutment
·
.
.
| Characteristic | New Device | K060291 | K072642 | K071551 | K061177 |
|---|---|---|---|---|---|
| Abutment Post | |||||
| Material | Titanium Alloy | ||||
| /ASTM F136 | Titanium Alloy /ASTM F136 and | ||||
| PEEK/ASTM F2026 | Titanium Alloy | ||||
| /ASTM F136 | Titanium Alloy | ||||
| /ASTM F136 | Titanium Alloy | ||||
| /ASTM F136 | |||||
| Surface | |||||
| Modifications | Titanium Nitride | ||||
| Coated Anodized | N/A | Laser marking | |||
| on Abutment | |||||
| Post | N/A | Anodized | |||
| Abutment | |||||
| Height | 5.44mm | ||||
| Abutment with | |||||
| Cap 6mm | 12mm (can be | ||||
| prepped to | |||||
| desired | |||||
| height) | 3, 4, 6, 8mm | 5.8mm | 5, 6, 7, 8, 9mm | ||
| Emergence | |||||
| Profile | 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 | |||
| Platform | |||||
| Diameter | 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 | Varies | ||
| depending on | |||||
| size (ranges | |||||
| from 0.25mm | |||||
| to 9.1mm) | 1.5mm | 1, 2, 3, 4mm | |||
| Design | Single unit | Single Unit/ | |||
| Multi-Unit | Single unit | Multi-unit | Single unit | ||
| Type | Abutment and cap | ||||
| system | Cylinder that | ||||
| can be | |||||
| prepped | Abutment only | Cylinder and cap | |||
| system | Abutment and | ||||
| temporary | |||||
| cylinder option | |||||
| Occlusal | |||||
| Loading | Non-occlusal | Nonocclusal | Nonocclusal | Non-occlusal | Non-occlusal |
| Abutment | |||||
| retention to | |||||
| implant | Screw | Screw | Screw | N/A - part of | |
| multi construct | Screw | ||||
| Connection to | |||||
| implant | Internal | Internal | |||
| External | Internal | ||||
| External | N/A - part of | ||||
| multi construct | Internal | ||||
| Abutment Cap | |||||
| Material | Polyetheretherketone | ||||
| (PEEK)/ ASTM | |||||
| F2026 | N/A | N/A | Polyetheretherketone | ||
| (PEEK)/ ASTM | |||||
| F2026 | Polyetheretherketone | ||||
| (PEEK)/ ASTM F2026 | |||||
| Surface Finish | Internal | Internal | |||
| External | Internal | ||||
| External | N/A - part of | ||||
| multi construct | Internal | ||||
| Cap Height | 4.0mm | N/A | N/A | 5.1mm | 6.5mm |
| Cap Margin | |||||
| Diameter | 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 to | |||||
| abutment | Snap | N/A | N/A | Snap/ cement | Cemented |
.
2
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. |
·
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body. The logo is rendered in black and white.
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.
4
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
5
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