(103 days)
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts:
- Telio CAD Abutment Solution
- Ti base and
- CAD/CAM software
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.
Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.
This document is a 510(k) premarket notification for a medical device called "Telio CAD Abutment Solutions." It focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices. The information provided heavily emphasizes physical, mechanical, and biological testing rather than artificial intelligence or diagnostic algorithms. Therefore, many of the typical acceptance criteria questions related to AI performance, such as sensitivity, specificity, or AUC, as well as aspects like reader studies, are not applicable here.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes tests performed and states the results were "comparable to the predicate device" or "suitable for use." The focus is on demonstrating equivalence rather than meeting specific numerical thresholds for improved performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties: | |
| Flexural strength comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Flexural modulus comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Water absorption comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Solubility comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Ball Hardness comparable to predicate | Internal Ball Hardness test conducted; showed comparable results with the predicate. |
| Dynamic fatigue performance suitable for temporary abutment use (up to 12 months) and comparable to predicate | Test conducted per EN ISO 14801:2007 (worst case); shows performance to be suitable for use as a temporary abutment and comparable to the predicate device. Additional and extensive testing performed to support 12 months temporary use (vs. predicate's 6 months). |
| Biocompatibility: | |
| Meets biocompatibility standards | Biocompatibility testing and evaluation carried out according to ISO 10993-1 and ISO 7504. |
| Design Parameters (Recommendations): | |
| Occlusal minimum thickness 1.5 mm | A recommendation for optimal performance is defined. |
| Circular minimum thickness 0.8 mm (transition to Ti base) | A recommendation for optimal performance is defined. |
| Rim minimum thickness 0.5 mm | A recommendation for optimal performance is defined. |
| Maximum angle 20º | A recommendation for optimal performance is defined. |
| Max width 6.0 mm from axial height of contour to screw channel | A recommendation for optimal performance is defined. |
| Observe implant manufacturer's maximum height recommendations | A recommendation for optimal performance is defined. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides details on types of testing (flexural, fatigue, biocompatibility) and the standards used (EN ISO 10477:2004, EN ISO 14801:2007, ISO 10993-1, ISO 7504). However, it does not specify the sample sizes (e.g., number of test specimens) used for each of these mechanical tests. It also doesn't mention the provenance of any "data" in terms of country of origin or whether it was retrospective/prospective, as this is typically relevant for clinical data, which is not the primary focus of this submission. The testing appears to be laboratory-based physical/mechanical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable. The device is a dental abutment, and its performance is evaluated through physical, mechanical, and biocompatibility testing, not through a diagnostic algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This question is not applicable. There is no "test set" in the context of expert review or diagnostic output that would require an adjudication method. The testing described is laboratory-based.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. MRMC studies are used to evaluate AI performance with human readers. This submission is for a physical medical device (dental abutment) and does not involve AI or human interpretation of diagnostic results.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. There is no algorithm or AI component mentioned in this submission. The device is a physical product.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through standardized laboratory testing and material characterization according to international ISO and EN standards. For example, flexural strength is measured directly, dynamic fatigue is assessed against defined cycles and loads, and biocompatibility is evaluated based on established biological safety protocols. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for a diagnostic tool.
8. Sample Size for the Training Set
This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set" or ground truth for such a set to be established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21,2015
Ivoclar Vivadent Ag % Donna Hartnett Director OA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K151564
Trade/Device Name: Telio CAD Abutment Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 19, 2015 Received: August 20, 2015
Dear Ms. Hartnett:
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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. 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
510(k) Number (if known) K151564
Device Name
Telio CAD Abutment Solutions
Indications for Use (Describe)
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts:
-
Telio CAD Abutment Solution
-
Ti base and
-
CAD/CAM software
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant system, CAD/CAM Systems and Ti bases arc shown below:
Implant Systems: Straumann Bone Level Implant (K0530g8), Biomed 3i Certain (K014235)
CAD/CAM System & Software: Sirona inLab and CEREC SW 4.2 and above (K100152 and K111421).
| Titanium bases (K100152 and K111421): | |||||
|---|---|---|---|---|---|
| Implant Manufacturer | Implant System | Implant Diameter | TiBase | Sirona Ref | Interface Size |
| Straumann | Bone Level RC | 4.1/4.8 | S BL 4.1 | 6308337 | L |
| Biomct 3i | Certain | 3.4 | BC 3.4 | 6308048 | S |
| Certain | 4.1 | BC 4.1 | 6308097 | L | |
| Certain | 5.0 | DC 5.0 | 6308121 | L |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY Rev 8.19.2015 Telio CAD Abutment Solutions
Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue and green, with the words "passion vision innovation" written in a smaller font below. Above the company name are several green and blue circles and squares. The logo is simple and modern, and it conveys a sense of professionalism and innovation.
Contact: Donna Marie Hartnett
| Company: | Ivoclar Vivadent, AG |
|---|---|
| Bendererstrasse 2, Schaan, FL-9494, Liechtenstein | |
| +423-235-3535 | |
| Date Prepared: | August 19, 2015 |
| Proprietary Name: | Telio CAD Abutment Solutions |
| Classification Name: | Abutment, Implant dental endosseous (872.3630)(Classification Code NHA) |
| Predicate Device: | IPS e.max CAD Abutment Solutions (K132209)Straumann CARES Variobase Temporary Abutments (K120822)Telio CAD (K093708) |
Device Description: Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.
Intended Use:
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts:
- Telio CAD Abutment Solution -
- Ti base and -
- CAD/CAM software -
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.
The compatible implant systems, CAD/CAM Systems and Ti bases are shown below:
Implant Systems: Straumann Bone Level Implant (K053088), Biomed 3i Certain (K014235)
CAD/CAM Systems: Sirona inLab and CEREC SW 4.2 and above
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510(K) SUMMARY Rev 8.19.2015 Telio CAD Abutment Solutions
Image /page/5/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is in blue, and the word "vivadent" is in blue below it. Above the words are a series of green and blue dots and squares arranged in an arc.
passion vision innovation
| ImplantMfg. | ImplantSystem | ImplantDiameter (mm) | Ti Base | Sirona Ref. | Interface size |
|---|---|---|---|---|---|
| Straumann | Bone Level RC | 4.1/4.8 | S BL 4.1 | 6308337 | L |
| Biomet 3i | Certain | 3.4 | BC 3.4 | 6308048 | S |
| 4.1 | BC 4.1 | 6308097 | L | ||
| 5.0 | BC 5.0 | 6308121 | L |
Titanium bases (K100152 and K111421):
Technological Characteristics: Telio CAD Abutment Solutions is a PMMA temporary restorative material (for periods up to 12 months) used with the Sirona Ti base. The device is currently indicated for use with a limited range of implant systems. Telio CAD Abutment Solutions is currently also limited to hybrid abutment crowns (i.e. top half of abutment mixed with full crown over Ti base abutment bottom-half). The contraindications are consistent with those of IPS e.max CAD Abutment Solutions and reflect the temporary usage of Telio CAD Abutment Solutions.
Specific design parameters for optimum performance are recommended. These are compared with those of the predicate device Straumann CARES Variobase Temporary Abutments (also a PMMA material). The following minimum thicknesses are defined for the hybrid abutment crown restoration:
Occlusal: minimum 1.5 mm Circular: minimum 0.8 mm in the transition area to the Ti base rim: minimum 0.5 mm Maximum angle 20º
The width of the hybrid abutment crown is limited to 6.0 mm from the axial height of contour to the screw channel. Depending on the dimensions of the Ti base interface (S or L) the block is selected to match. The recommendations of the implant manufacturer regarding maximum height must be observed.
Concerning the recommended sterilization procedure these are the same as the previously cleared predicate Straumann CARES Variobase Temporary Abutments, which is also a PMMA temporary abutment material.
Testing Summary:
- (a) The device has been tested for flexural strength. Flexural modulus. Water absorption and Solubility according to EN ISO 10477:2004 Dentistry - Polymer based crown and bridge materials and the results are comparable to the predicate Device TelioCAD.
- (b) An internal Ball Hardness test was also conducted and showed comparable results with the predicate.
- (c) Dynamic fatigue testing for these implant systems (worst case) with Telio CAD Abutment Solutions has been carried out according to EN ISO 14801:2007 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) and shows the performance to be suitable for use as a temporary abutment and comparable to the predicate device.
- (d) Biocompatibility testing and evaluation was also carried out according to ISO 10993-1 and ISO 7504.
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510(K) SUMMARY
Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is on top of the word "vivadent". Above the words are a series of green and blue circles and squares.
passion vision innovation
| Summary Substantial Equivalence compared to Predicate Device | ||||
|---|---|---|---|---|
| Device Name | Telio CAD AbutmentSolutions K151564 | Primary predicate:IPS e.max CADAbutment SolutionsK132209 | StraumannCARESVariobaseTemporaryabutmentsK120822 | Telio CADK093708 |
| Company Name | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Straumann | Ivoclar VivadentAG |
| 510(k) No. | K151564 | K132209 | K120822 | K093708 |
| Product Code | NHA | NHA | NHA | EBG |
| Compatible ImplantTypes | St Bone Level RC4.1,4.8 (K053088)Biomet Certain 3.4Biomet Certain 4.1Biomet Certain 5.0(K014235) | NB Replace NP 3.5NB Replace RP 4.3NB Replace WP 5.0NB Replace 6.0NB Active NP 3.5NB Active RP 4.3,5.0St Bone Level NC 3.3St Bone Level RC4.1,4.8Biomet Certain 3.4Biomet Certain 4.1Biomet Certain 5.0 | Straumann NNC,RN, WN, NC, RC | Not relevant |
| Indications for Useor Intended use | Single hybrid abutmentcrowns for temporaryrestoration (up to 12months) | In partially or fullyedentulous mandiblesand maxillae in supportof single cement-retained restorations. | Temporaryrestoration (up to180 days) of aStraumann dentalimplant | For temporarycrowns andbridges |
| Custom Design | ||||
| Maximal abutmentangulation | 20° | 20° | No information | Not relevant |
| Abutment diameter | Limited by oral situation.Max width is limited to6mm from axial heightof contour to the screwchannel | Limited by oral situation.Max width is limited to6mm from axial heightof contour to the screwchannel | No information | Not relevant |
| Abutment height | Follow recommendationof implant manufacturer | Follow recommendationof implant manufacturer | No information | Not relevant |
| Retention | Abutment parts lutedwith self-curing lutingcomposite | Abutment parts lutedwith self-curing lutingcomposite | Coping cementedto abutment | Restorationluted with dualcure temporaryluting compositeto core |
| Abutment fixation | Screwed | Screwed | Screwed | Not relevant |
| 1 or 2 pieceabutment | 2 piece: Telio CAD withTiBase | 2 piece: IPS e.max CADwith TiBase | 2 piece: copingwith abutment | Not relevant |
| CAD/CAMprocessing | TelioCAD milled withSirona CEREC/inLabTiBase milled inmanufacturer'sproduction facility | IPS e.max CAD milledwith SironaCEREC/inLabTiBase milled inmanufacturer'sproduction facility | StraumannCARES Scan,Straumann millingcentre | SironaCEREC/inLab,PlanMill |
| Device Name | Telio CAD AbutmentSolutions K151564 | Primary predicate:IPS e.max CADAbutment SolutionsK132209 | StraumannCARESVariobaseTemporaryabutmentsK120822 | Telio CADK093708 |
| Material | ||||
| Abutment | Metal Base titaniumCoping - PMMAScrew - Titanium | Metal Base - titaniumCoping - CeramicScrew - Titanium | PMMA + titanium-aluminium-niobium alloy | Not relevant |
| Screw | Part of implant system | Part of implant system | Titanium-aluminium-niobium | Not relevant |
| Mechanical Testing | Dynamic fatigue testing. | Dynamic fatiguetesting. | Dynamic fatiguetesting. The testspecimenspassed thepredefinedacceptancecriteria. | Physicalproperty testing.The testspecimens passthe predefinedacceptancecriteria. |
| Sterile | No | No | No | No |
| Reusable | No | No | No | No |
| Principles ofOperation (for theDentist/Technician) | ScanningDesigningMillingLutingFinishing | ScanningDesigningMillingLutingFinishing | ScanningDesigningScrewing.Milling, luting andfinishing provided | ScanningDesigningMillingFinishingTemporary |
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510(K) SUMMARY Rev 8.19.2015 Telio CAD Abutment Solutions
Image /page/7/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is in blue, and the word "vivadent" is in blue below it. Above the words are a series of green and blue dots and squares.
passion vision innovation
CONCLUSION: Telio CAD Abutment Solutions is a variation on the previously cleared predicate Telio CAD. Telio CAD Abutment Solutions is used as a temporary hybrid abutment crown in conjunction with the Sirona Ti base which can later be permanently restored using IPS e.max CAD Abutment Solutions. The subject device differs from the primary predicate device KK132209 in that the primary predicate is a permanent abutment. This difference is addressed by use of a reference predicate K120822 which is also a temporary abutment device. The subject device also is intended for use up to 12 months, while the reference predicate K120882 is intended for use up to 6 months; the sponsor performed additional and extensive testing to support the additional 6 months temporary use of the subject device. The documentation show that Telio CAD Abutment Solutions is substantially equivalent to the predicate devices, IPS e.max CAD Abutment Solutions, Straumann CARES Variobase Temporary Abutments and Telio CAD.
§ 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.)