Telio CAD Abutment Solutions

K151564 · Ivoclar Vivadent, AG · NHA · Sep 21, 2015 · Dental

Device Facts

• Record ID: K151564
• Device Name: Telio CAD Abutment Solutions
• Applicant: Ivoclar Vivadent, AG
• Product Code: NHA · Dental
• Decision Date: Sep 21, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Device consists of PMMA resin blocks with interface hole; used to fabricate temporary hybrid abutment crowns via CAD/CAM milling. System components: Telio CAD block, Sirona Ti base, and CAD/CAM software. Clinician scans patient, designs restoration, mills block, and cements to Ti base. Final assembly screwed into endosseous dental implant. Used in dental clinics; operated by dentists/technicians. Output is patient-specific temporary crown; aids in maintaining esthetics and function during healing period (up to 12 months). Benefits patient by providing temporary restoration while awaiting permanent solution.

Clinical Evidence

Bench testing only. Performed flexural strength, flexural modulus, water absorption, and solubility testing per EN ISO 10477:2004. Conducted internal ball hardness testing. Performed dynamic fatigue testing per EN ISO 14801:2007. Biocompatibility testing performed per ISO 10993-1 and ISO 7504. Results demonstrate performance comparable to predicate devices.

Technological Characteristics

Material: PMMA (cross-linked polymer). Components: PMMA block, titanium base, titanium screw. Sensing/Actuation: None (mechanical/restorative). Dimensions: Max 20-degree angulation, min 1.5mm occlusal thickness, min 0.8mm circular thickness. Connectivity: Compatible with Sirona inLab/CEREC CAD/CAM systems. Sterilization: Not provided sterile. Software: CAD/CAM design software.

Indications for Use

Indicated for single hybrid abutment crowns for temporary restoration (up to 12 months) in patients requiring temporary tooth replacement using endosseous dental implants.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• IPS e.max CAD Abutment Solutions (K132209)
• Straumann CARES Variobase Temporary Abutments (K120822)
• Telio CAD (K093708)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 |
| | [phone] |
| Date Prepared: | August 19, 2015 |
| Proprietary Name: | Telio CAD Abutment Solutions |
| Classification Name: | Abutment, Implant dental endosseous (872.3630)<br>(Classification Code NHA) |
| Predicate Device: | IPS e.max CAD Abutment Solutions (K132209)<br>Straumann CARES Variobase Temporary Abutments (K120822)<br>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

| Implant<br>Mfg. | Implant<br>System | Implant<br>Diameter (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 Abutment<br>Solutions K151564 | Primary predicate:<br>IPS e.max CAD<br>Abutment Solutions<br>K132209 | Straumann<br>CARES<br>Variobase<br>Temporary<br>abutments<br>K120822 | Telio CAD<br>K093708 |
| Company Name | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Straumann | Ivoclar Vivadent<br>AG |
| 510(k) No. | K151564 | K132209 | K120822 | K093708 |
| Product Code | NHA | NHA | NHA | EBG |
| Compatible Implant<br>Types | St Bone Level RC<br>4.1,4.8 (K053088)<br>Biomet Certain 3.4<br>Biomet Certain 4.1<br>Biomet Certain 5.0<br>(K014235) | NB Replace NP 3.5<br>NB Replace RP 4.3<br>NB Replace WP 5.0<br>NB Replace 6.0<br>NB Active NP 3.5<br>NB Active RP 4.3,5.0<br>St Bone Level NC 3.3<br>St Bone Level RC<br>4.1,4.8<br>Biomet Certain 3.4<br>Biomet Certain 4.1<br>Biomet Certain 5.0 | Straumann NNC,<br>RN, WN, NC, RC | Not relevant |
| Indications for Use<br>or Intended use | Single hybrid abutment<br>crowns for temporary<br>restoration (up to 12<br>months) | In partially or fully<br>edentulous mandibles<br>and maxillae in support<br>of single cement-<br>retained restorations. | Temporary<br>restoration (up to<br>180 days) of a<br>Straumann dental<br>implant | For temporary<br>crowns and<br>bridges |
| Custom Design | | | | |
| Maximal abutment<br>angulation | 20° | 20° | No information | Not relevant |
| Abutment diameter | Limited by oral situation.<br>Max width is limited to<br>6mm from axial height<br>of contour to the screw<br>channel | Limited by oral situation.<br>Max width is limited to<br>6mm from axial height<br>of contour to the screw<br>channel | No information | Not relevant |
| Abutment height | Follow recommendation<br>of implant manufacturer | Follow recommendation<br>of implant manufacturer | No information | Not relevant |
| Retention | Abutment parts luted<br>with self-curing luting<br>composite | Abutment parts luted<br>with self-curing luting<br>composite | Coping cemented<br>to abutment | Restoration<br>luted with dual<br>cure temporary<br>luting composite<br>to core |
| Abutment fixation | Screwed | Screwed | Screwed | Not relevant |
| 1 or 2 piece<br>abutment | 2 piece: Telio CAD with<br>TiBase | 2 piece: IPS e.max CAD<br>with TiBase | 2 piece: coping<br>with abutment | Not relevant |
| CAD/CAM<br>processing | TelioCAD milled with<br>Sirona CEREC/inLab<br>TiBase milled in<br>manufacturer's<br>production facility | IPS e.max CAD milled<br>with Sirona<br>CEREC/inLab<br>TiBase milled in<br>manufacturer's<br>production facility | Straumann<br>CARES Scan,<br>Straumann milling<br>centre | Sirona<br>CEREC/inLab,<br>PlanMill |
| Device Name | Telio CAD Abutment<br>Solutions K151564 | Primary predicate:<br>IPS e.max CAD<br>Abutment Solutions<br>K132209 | Straumann<br>CARES<br>Variobase<br>Temporary<br>abutments<br>K120822 | Telio CAD<br>K093708 |
| Material | | | | |
| Abutment | Metal Base titanium<br>Coping - PMMA<br>Screw - Titanium | Metal Base - titanium<br>Coping - Ceramic<br>Screw - Titanium | PMMA + titanium-<br>aluminium-<br>niobium alloy | Not relevant |
| Screw | Part of implant system | Part of implant system | Titanium-<br>aluminium-<br>niobium | Not relevant |
| Mechanical Testing | Dynamic fatigue testing. | Dynamic fatigue<br>testing. | Dynamic fatigue<br>testing. The test<br>specimens<br>passed the<br>predefined<br>acceptance<br>criteria. | Physical<br>property testing.<br>The test<br>specimens pass<br>the predefined<br>acceptance<br>criteria. |
| Sterile | No | No | No | No |
| Reusable | No | No | No | No |
| Principles of<br>Operation (for the<br>Dentist/Technician) | Scanning<br>Designing<br>Milling<br>Luting<br>Finishing | Scanning<br>Designing<br>Milling<br>Luting<br>Finishing | Scanning<br>Designing<br>Screwing.<br>Milling, luting and<br>finishing provided | Scanning<br>Designing<br>Milling<br>Finishing<br>Temporary |

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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.