(317 days)
No
The summary describes a physical dental abutment and its compatibility with a CAD/CAM system, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
Explanation: The device is an abutment for dental implants designed to support prosthetic restorations (single tooth or bridge), which serves to treat a missing tooth or teeth.
No
This device is an abutment for dental implants, providing support for prosthetic restorations. It is a structural component of a dental restoration system, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a two-piece abutment made of titanium alloy, which is a physical hardware component. While it is used in conjunction with software (Sirona CEREC Premium SW 4.2), the device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Klockner Vega TiBase for CEREC® abutments are described as titanium alloy abutments placed onto dental implants to support prosthetic restorations (crowns and bridges). Their function is mechanical support within the mouth.
- Lack of Biological Specimen Interaction: The device does not interact with or analyze biological specimens from the human body for diagnostic purposes.
- Focus on Mechanical and Structural Performance: The performance studies mentioned (dimensional verification, dynamic fatigue, bending assays) are focused on the mechanical and structural integrity of the device and its compatibility with the CAD/CAM system, not on analyzing biological samples.
Therefore, the Klockner Vega TiBase for CEREC® abutments are considered a dental prosthetic component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Klockner Vega TiBase for CEREC® abutments are two-piece abutment (composed of the ti-base component and a ceramic mesostructure or coping) fabricated by using the Sirona Dental CAD/CAM System and are to be used with Klockner Vega Dental Implant Systems, with conical and hexagonal internal connection, platforms MV, NV, RV.
The Klockner Vega TiBase for CEREC® are Ti-base abutments, made of titanium alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC® systems, and the base portion is available in three models to fit three Klockner® dental implant platforms.
The Klockner Vega TiBase for CEREC® abutments are compatible with the previously cleared material inCoris ZI, L size blank (Sirona inCoris ZI meso zirconium dioxide, ZrCO2) within the 510ks K100152 and K111421.
The Klockner Vega TiBase for CEREC® abutments are compatible with copings and crowns fabricated using the following previously cleared mills:
• Sirona Dental CAD/CAM System (introduction of the Sirona SSO series Tibases compatible with the Straumann Tissue Level implants) cleared to market per K100152.
The functionality necessary to design and produce abutments compatible with the Klockner Vega TiBase for CEREC® abutments (as well as the Sirona SSO series Ti-bases) has been verified. Copings and crowns designed using the Premium Sirona CEREC Software version 4.2, within the design limits as defined within the design software, are compatible with the Klockner Vega TiBase for CEREC® abutments. Thus, in order to design prosthetic restorations on Klockner Vega TiBase for CEREC® abutments using Sirona software, compatible scanbodies and Ti-Bases from a defined Sirona library must be chosen and Sirona work-flow, followed. Milling block size and a set of maximum and minimum design parameters are both selectable by the user.
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)
Non-Clinical Data:
Biocompatibility: All materials used in the manufacture of Klockner Vega TiBase for CEREC® have been subject to biological evaluation taking account the intended use of the devices and the nature and duration of contact with the patient. Requirements of applicable recognized standards have been considered and, when appropriate, biological testing has been performed:
- Biocompatibility of the subject devices is confirmed by conformance to FDA recognized consensus material standards (titanium alloy conforming to ASTM F136). The manufacturing processes and materials for the Ti Base are identical to those used for Klockner Implant System components previously cleared in K153098.
Sterilization: Klockner Vega TiBase for CEREC® abutments have been subject to bioburden and sterility testing in accordance with ISO 11737-1 and ISO 11737-2, respectively. Steam sterilization validation according to ISO 17665-1 and ISO/TS 17665-2 has been carried out to confirm the sterilization parameters.
Bench testing: - Dimensional verification assuring the compatibility with Sirona InCoris and the appropriate fit of the milling coping on the abutment.
- Laboratory bench testing, including dimensional analysis and dynamic fatigue and bending assays, has been performed considering worst-case conditions for the Klockner Veqa TiBase for CEREC® abutments with cemented InCoris coping according to ISO 14801 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants.
- Process validation of the Klockner Vega TiBase for CEREC® within the Sirona CEREC® workflow.
Clinical Data:
No clinical data are included in this submission.
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.
K153098, K111421, K100152, K101732
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.)
0
Image /page/0/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 abstract symbol that resembles a stylized caduceus or a representation of the human form. The symbol is composed of three overlapping profiles facing to the right, suggesting a sense of unity and progress.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2017
SOADCO S.L. Maria Mitjaneta Quality Manager Avgda. Fiter I Rosell, 4 Bis - Local 2 Escaldes - Engordany, AD-700 ANDORRA
Re: K170022
Trade/Device Name: Klockner Vega TiBase For CEREC® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 9, 2017 Received: October 19, 2017
Dear Maria Mitjaneta:
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.
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
1
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 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows a logo with the text "SOAD" in a stylized font. The letters are large and bold, with the "S" and "D" being particularly prominent. In the middle of the logo, there is a globe graphic, suggesting an international or global theme. Below the globe, the text "for KLOCKNER" is written in a smaller font, indicating a connection or affiliation with the company KLOCKNER.
INDICATIONS FOR USE
510(k) Number (if known): K170022
Klockner Vega TiBase for CEREC® Device Name:
Indications for Use:
The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Prescription Use V AND / OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
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Image /page/3/Picture/1 description: The image shows the logo for SOAD for Klockner. The logo is in black and white, with the letters "SOAD" in bold black font. To the right of the letters is a globe. Below the globe is the text "for KLOCKNER" in a smaller font. The letters are on a gray background.
510(k) SUMMARY K170022
| Date of submission: | 2017-11-14 |
|---|---|
| Submitter name: | SOADCO, S.L. |
| Submitter address: | Avgda. Fiter i Rossell, 4bis - Local 2 |
| ESCALDES - ENGORDANY | |
| AD-700 (ANDORRA) | |
| Contact person: | Maria Mitjaneta |
| Phone: | +376 800 590 |
| Fax: | +376 800 594 |
| e-mail: | calidad@soadco.com |
| Device Trade Name: | Klockner Vega TiBase for CEREC® |
| Common Name: | Dental Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulation Number: | 21 CFR 872.3630 |
| Class: | Class II (Special controls) |
| Panel: | Dental |
| Product code: | NHA |
Predicate Devices:
| 510(k) Number
| Predicate Device | Device Trade Name | Manufacturer |
|---|---|---|
| K151324 | Straumann® Variobase® for CEREC | Straumann USA, LLC |
| Reference
Devices | 510(k)
Number | Device Trade Name | Manufacturer |
|----------------------|------------------|------------------------------------------------------|----------------------------|
| 1 | K153098 | KLOCKNER Vega Dental Implant
System | SOADCO, S.L. |
| 2 | K111421 | Sirona Dental CAD/CAM System | Sirona Dental Systems GmbH |
| 3 | K100152 | Sirona Dental CAD/CAM System | Sirona Dental Systems GmbH |
| 4 | K101732 | Astra Tech Implant System,
OsseoSpeed TX implants | Astra Tech AB |
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Image /page/4/Picture/1 description: The image shows a logo with the letters "SOAD" in black, with a globe in place of the "O". The words "for KLOCKNER" are written in a smaller font below the globe. The letters "AND" are in gray and are behind the letters "SOAD". The logo is likely for a company or organization.
Device Description:
Klockner Vega TiBase for CEREC® abutments are two-piece abutment (composed of the ti-base component and a ceramic mesostructure or coping) fabricated by using the Sirona Dental CAD/CAM System and are to be used with Klockner Vega Dental Implant Systems, with conical and hexagonal internal connection, platforms MV, NV, RV.
The Klockner Vega TiBase for CEREC® are Ti-base abutments, made of titanium alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC® systems, and the base portion is available in three models to fit three Klockner® dental implant platforms. The new components introduced in this 510(k) are shown below.
| Catalog Number
| (Reference) | Description |
|---|---|
| 18 10 25 | NV VEGA Ti-BASE PILAR |
| 18 10 65 | RV VEGA Ti-BASE PILAR |
| 18 10 98 | MV VEGA Ti-BASE PILAR |
The Klockner Vega TiBase for CEREC® abutments are compatible with the previously cleared material inCoris ZI, L size blank (Sirona inCoris ZI meso zirconium dioxide, ZrCO2) within the 510ks K100152 and K111421.
The Klockner Vega TiBase for CEREC® abutments are compatible with copings and crowns fabricated using the following previously cleared mills:
• Sirona Dental CAD/CAM System (introduction of the Sirona SSO series Tibases compatible with the Straumann Tissue Level implants) cleared to market per K100152.
The functionality necessary to design and produce abutments compatible with the Klockner Vega TiBase for CEREC® abutments (as well as the Sirona SSO series Ti-bases) has been verified. Copings and crowns designed using the Premium Sirona CEREC Software version 4.2, within the design limits as defined within the design software, are compatible with the Klockner Vega TiBase for CEREC® abutments. Thus, in order to design prosthetic restorations on Klockner Vega TiBase for CEREC® abutments using Sirona software, compatible scanbodies and Ti-Bases from a defined Sirona library must be chosen and Sirona work-flow, followed. Milling block size and a set of maximum and minimum design parameters are both selectable by the user.
Indications for Use:
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Image /page/5/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, and the letters are large and bold. The letters are arranged in a slightly curved line, and the word "for KLOCKNER" is written in smaller letters below the letters SOAD. There is a globe in the middle of the logo.
The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Substantial Equivalence:
In the establishment of substantial equivalence, Klockner Vega TiBase for CEREC® are compared to the primary predicate device with the same indications for use, the same coronal portion design and similar material (Titanium Alloy). The subject Klockner Vega TiBase for CEREC® abutments are functionally equivalent to the primary predicate Straumann® Variobase® for CEREC® abutments and to the reference device Dental CAD/CAM system abutments (K100152 and K111421). The difference is that the base design portion of these abutments has been designed to interface with the Klockner Vega Implants with conical and hexagonal internal connection, platforms MV, NV, RV and not for the implant platforms which the predicate device describes.
The coronal geometry of the subject devices is equivalent to the coronal geometry of the reference devices (K111421 and K100152), therefore copings and crowns fabricated using the Sirona software and milling systems will be compatible with the subject devices.
There have been no changes to the materials, packaging, or recommended sterilization method parameters for these devices as compared to the reference device Klockner Vega Dental Implant System (K153098).
Indications for use and technological characteristics have been compared with the predicate device and reference devices (see next pages), following the guidelines set out in guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Features of proposed device not shared with predicate devices have been substantiated using a reference device.
All issues affecting safety and performance have been reviewed and discussed. Any differences have been addressed in the bench testing performed on the proposed device.
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Image /page/6/Picture/1 description: The image is a logo that says "SOAD" in a stylized font. The letters are in black and are outlined in white. The background is gray. The letter "O" in "SOAD" has a globe in the center of it. Below the globe, it says "for KLOCKNER" in a smaller font.
| Device | Indications for Use |
|---|---|
| Proposed device: | |
| Klockner Vega | |
| TiBase for CEREC® | The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. |
| Predicate device: | |
| K151324 | |
| Straumann® | |
| Variobase® for | |
| CEREC® | The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. |
| Reference device 1: | |
| K153098 | |
| KLOCKNER Vega | |
| Dental Implant | |
| System | The KLOCKNER® VEGA® dental implant system is indicated to replace missing teeth in single and multiple unit applications within the mandible or maxilla. Implants can be for immediate placement and function in extraction sites and partially or completely healed alveolar ridge situations, when good primary stability is achieved and with appropriate occlusal loading. Different loading protocols (immediate, early or delayed) can be applied in partially or totally edentulous patients. The prosthetic restorations can be single-unit or multiple-unit restorations. The Ø 3.0 mm implants should only be used for unit restorations for maxillary lateral incisors and mandibular lateral and central incisors. |
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Image /page/7/Picture/1 description: The image shows a logo for SOAD for KLOCKNER. The logo is in gray and black, and it features the letters "SOAD" in a stylized font. The "O" in SOAD is replaced by a globe. Below the globe, the text "for KLOCKNER" is written in a smaller font.
| Device | Indications for Use |
|---|---|
| Reference device 2: | |
| K111421 | |
| Sirona Dental | |
| CAD/CAM System | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous |
| mandibles and maxilla in support of single or multiple-unit cement retained | |
| restorations. For the titanium bases SSO 3.5 L and SBL 3.3 L, the indication is | |
| restricted for replacement of single lateral incisors in the maxilla and lateral and central | |
| incisors in the mandible. The system consists of three major parts: TiBase, | |
| inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris | |
| mesostructure and TiBase components make up a two-piece abutment which is used | |
| in conjunction with endosseous dental implants to restore the function and aesthetics | |
| in the oral cavity. The inCoris mesostructure may also be used in conjunction with the | |
| Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the | |
| Camlog Implant System. The CAD/CAM software is intended to design and fabricate | |
| the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment | |
| is compatible with the following implants systems: |
- Nobel Biocare Replace (K020646)
- Nobel Biocare Branemark (K022562)
- Friadent Xive (K013867)
- Biomet 3i Osseotite (K980549)
- Astra Tech Osseospeed (K09 1239)
- Zimmer Tapered Screw-Vent (K0614 10)
- Straumami SynOcta (K061 176)
- Straumann Bone Level (K053088, K062 129, K060958)
- Biomet 3i Certain (K014235, K061629)
- Nobel Biocare Active (K071370) |
| Reference device 3:
K100152
Sirona Dental
CAD/CAM System | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous
mandibles and maxilla in support of single or multiple-unit cement retained
restorations. The system consists of three major parts: TiBase, InCoris mesostructure,
and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase
components make up a two-piece abutment which is used in conjunction with
endosseous dental implants to restore the function and aesthetics in the oral cavity.
The InCoris mesostructure may also be used in conjunction with the Camlog Titanium
base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The
CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The
InCoris mesostructure and TiBase two-piece abutment is
compatible with the following implants systems: - Nobel Biocare Replace (K020646)
- Nobel Biocare Branemark (K022S62)
- Friadent Xive (K013867)
- Biomet 3i Osseotite (K980S49!)
- Astra Tech Osseospeed (K09 1239)
- Zimmer Tapered Screw-Vent (K(061410)
- Straumann SynOcta (K(061176)) |
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Image /page/8/Picture/1 description: The image shows a logo with the letters "SOAD" in a stylized font. The letters are arranged in a slightly curved line, with the "S" and "D" being larger than the "O" and "A". To the right of the letters is a globe graphic, and below the letters is the text "for KLOCKNER". The entire logo is in a grayscale color scheme.
| Device | Indications for Use |
|---|---|
| Reference device 4: | |
| K101732 | |
| Astra Tech Implant | |
| System, OsseoSpeed | |
| TX implants | The OssseoSpeed implants are intended to be used: |
| to replace missing teeth in single and multiple unit applications within the mandible or maxilla for immediate placement in extraction sites and partially or completely healed alveolar ridge situations for both one- and two-stage surgical procedures especially well in soft bone applications where implants with other implant surface treatments may be less effective together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate together with immediate loading protocol for single-tooth restorations on implants 8 mm or longer with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and central incisors. | |
| Equivalence | |
| Discussion | Substantially equivalent in reference the coronal portion of proposed device respect the predicate Device. Coronal aspect of proposed device is designed to interface with copings/crowns fabricated from milling blanks containing pre-machined holes for use with the CEREC® CADCAM system which is the same than predicate device and the reference device 2 and 3. |
| The workflows used to design and fabricate the restorations are the same than the predicate device and the reference device 2 and 3. | |
| The base design portion of the proposed device has been designed to interface with the Klockner Vega Implants; therefore these implants are different than the predicate devices but are the same than the reference device 1 and substantial equivalence to the reference device 4. The prosthetic restorations are the same for all predicate devices and reference devices. |
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Image /page/9/Picture/1 description: The image shows the logo for SOAD for Klockner. The logo is in gray and features the letters "SOAD" in a stylized font. The "O" in "SOAD" is replaced with a globe graphic. Below the globe is the text "for KLOCKNER" in a smaller font.
| Features | PROPOSED DEVICE:
Klockner Vega
TiBase for CEREC® | PREDICATE DEVICE:
K151324
(Straumann®
Variobase® for
CEREC®) | REFERENCE DEVICE
1:
K153098
(Klockner Vega
Dental Implant
System) | REFERENCE DEVICE
2 / 3:
K100152 / K111421
(Sirona Dental
CAD/CAM System) | REFERENCE
DEVICE 4:
K101732
(Astra Tech Implant
System,
OsseoSpeed TX
implants) | Equivalence Discussion |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Ti-base Material | Titanium-Aluminium-
Vanadium Alloy (Ti-6Al-4Va) | Titanium-Aluminum-
Niobium
alloy (Ti-6Al-7Nb) | Titanium-Aluminium-
Vanadium Alloy (Ti-6Al-
4Va) for the abutments | Titanium-Aluminium-
Vanadium Alloy (Ti-6Al-
4Va) | Titanium-Aluminium-
Vanadium Alloy (Ti-6Al-
4Va) for the abutments | Substantially equivalent. All
materials are Titanium alloy. |
| Coping/Crown
Material | Compatible with the Sirona
Dental System inCoris ZI
Meso L (K100152 /
K111421). | Compatible with any
milling blanks cleared for
use with the CEREC MC
X and MC XL milling
systems (i.e., containing
the pre-machined
mounting hole). Currently
available:
inCoris ZI meso
(K123664)
Ivoclar IPS e.max CAD
(K132209)
Ivoclar Telio CAD
(K093708) | N/A | Sirona Dental System
inCoris ZI Meso L | N/A | Same |
| Implant
Compatibility | Klockner Vega Implants
(bone level) | Straumann implants
(tissue level and bone
level) | Vega Klockner Implants
(bone level) | Nobel Biocare / Friadent /
Biomet 3i / Astra Tech /
Zimmer / Straumann
(tissue level and bone
level) | Astra Tech implants
(bone level) | Substantially Equivalent |
| Design - Abutment
Diameter (base) mm | 4.5 - 7 | 4.5 - 7 | 3.65 | 3.3., 3.4, 3.5, 3.8, 4.0,
4.1, 4.3, 4.5, 4.8, 5.0,
5.5, 5.7, 6.0, 6.5 | | Same |
| Features | PROPOSED DEVICE:
Klockner Vega
TiBase for CEREC® | PREDICATE DEVICE:
K151324
(Straumann®
Variobase® for
CEREC® | REFERENCE DEVICE 1:
K153098
(Klockner Vega
Dental Implant
System) | REFERENCE DEVICE
2 / 3:
K100152 / K111421
(Sirona Dental
CAD/CAM System) | REFERENCE
DEVICE 4:
K101732
(Astra Tech Implant
System,
OsseoSpeed TX
implants) | Equivalence Discussion |
| Design - Abutment
Height (mm) | 4.7 | 4.7 | 4.7 | 4.7 | 4.7 | Same |
| Abutment
Angulation | up to 20° | up to 20° | N/A | up to 20° | up to 20° | Same |
| Design Workflow | Per the Premium Sirona
CEREC, software version
4.2. | Per the Sirona CEREC
InLab, software version
3.6 or later. | N/A | Per the Sirona Dental
CAD/CAM Software. | N/A | Substantially equivalent |
| Manufacturing
Workflow | Per Sirona Cerec milling
systems | Per the Sirona Cerec MC
X and MC XL milling
systems | N/A | Per Sirona Cerec milling
systems | N/A | Same |
| Mode of Attachment | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or
cement retained | Same |
| Reusable | No | No | No | No | No | Same |
| Sterility | Provided non-sterile.
These devices are
individually packed and
provided non-sterile, but
intended to be sterilized
before placement in the
mouth. Instructions for use
contain the recommended
sterilization process
validated as per standard
ISO 17665-1 and standard
ISO/TS 17665-2. | Predicate devices are
also provided non-sterile.
As proposed devices,
these predicates are
individually packed and
provided non-sterile, but
intended to be sterilized
before placement in the
mouth. The same
sterilization process
(validated as per ISO
17665-1) is
recommended. | Reference devices are
also provided non-sterile.
As proposed devices,
these predicates are
individually packed and
provided non-sterile, but
intended to be sterilized
before placement in the
mouth. The same
sterilization process
(validated as per ISO
17665-1) is
recommended. | Reference devices are
also provided non-sterile.
As proposed devices,
these predicates are
individually packed and
provided non-sterile, but
intended to be sterilized
before placement in the
mouth. The same
sterilization process
(validated as per ISO
17665-1) is
recommended. | Reference devices are
also provided non-sterile.
As proposed devices,
this predicate is
individually packed and
provided non-sterile, but
intended to be sterilized
before placement in the
mouth. The same
sterilization process
(validated as per ISO
17665-1) is
recommended. | Same |
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Image /page/10/Picture/1 description: The image shows the logo for SOADCO for Klockner. The logo is in black and white and features the letters "SOADCO" in a stylized font. The "O" in "SOADCO" is replaced with a globe. The words "for Klockner" are written in a smaller font below the globe. The entire logo is superimposed on a larger, gray "AND".
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Image /page/11/Picture/1 description: The image shows a logo with the text "SOAD" in a bold, sans-serif font. The letters are arranged horizontally, with the "O" containing a graphic of the earth. Below the text "SOAD" is the text "for KLOCKNER" in a smaller font. The logo is in grayscale and has a modern, corporate feel.
Summary Discussion of Non-Clinical Data:
· Biocompatibility
All materials used in the manufacture of Klockner Vega TiBase for CEREC® have been subject to biological evaluation taking account the intended use of the devices and the nature and duration of contact with the patient. Requirements of applicable recognized standards have been considered and, when appropriate, biological testing has been performed:
- -Biocompatibility of the subject devices is confirmed by conformance to FDA recognized consensus material standards (titanium alloy conforming to ASTM F136). The manufacturing processes and materials for the Ti Base are identical to those used for Klockner Implant System components previously cleared in K153098.
- . Sterilization
Klockner Vega TiBase for CEREC® abutments have been subject to bioburden and sterility testing in accordance with ISO 11737-1 and ISO 11737-2, respectively. Steam sterilization validation according to ISO 17665-1 and ISO/TS 17665-2 has been carried out to confirm the sterilization parameters.
- · Bench testing
- -Dimensional verification assuring the compatibility with Sirona InCoris and the appropriate fit of the milling coping on the abutment.
- -Laboratory bench testing, including dimensional analysis and dynamic fatigue and bending assays, has been performed considering worst-case conditions for the Klockner Veqa TiBase for CEREC® abutments with cemented InCoris coping according to ISO 14801 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants.
- -Process validation of the Klockner Vega TiBase for CEREC® within the Sirona CEREC® workflow.
Summary Discussion of Clinical Data:
No clinical data are included in this submission.
Conclusions:
We consider that the intended use, the indications for use, the operation principle and the technological characteristics of Klockner Vega TiBase for CEREC® are equivalent to those of predicate devices. The documentation submitted in this premarket notification confirms that, even though minor technological differences may exist, the submission device is substantially equivalence to the predicate devices. Therefore, substantial equivalence of Klockner Vega TiBase for CEREC® to the predicate devices may be established.