IPS E.MAX CAD ABUTMENT SOLUTIONS

K132209 · Ivoclar Vivadent, AG · NHA · Oct 31, 2013 · Dental

Device Facts

• Record ID: K132209
• Device Name: IPS E.MAX CAD ABUTMENT SOLUTIONS
• Applicant: Ivoclar Vivadent, AG
• Product Code: NHA · Dental
• Decision Date: Oct 31, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: IPS e.max CAD mesostructure, Ti base and CAD/CAM software. The IPS e.max CAD mesostructure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, Ti bases and CAD/CAM systems are shown below: Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549) CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above. For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

Device Story

System comprises lithium disilicate ceramic blocks, premanufactured titanium bases, and CAD/CAM software. Trained professionals use Sirona inLab or Cerec SW 4.2+ software to design and mill ceramic mesostructures from blocks. Mesostructure is extraorally cemented to titanium base to form a two-piece hybrid abutment or hybrid abutment crown. Final assembly is screwed onto endosseous dental implants in the oral cavity. Device restores function and esthetics for single tooth restorations. Clinical benefit derived from patient-specific CAD/CAM design and durable lithium disilicate material.

Clinical Evidence

Bench testing only. Fatigue testing performed on angled abutments per FDA guidance 'Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments'. Physical properties (flexural strength, fracture toughness, chemical solubility) verified against ISO 6872 standards.

Technological Characteristics

Lithium disilicate (Li2Si2O5) dental ceramic blocks; titanium alloy bases. CAD/CAM milling process. Complies with ISO 6872:2008 for dental ceramics. Connectivity via Sirona inLab/Cerec software. Two-piece hybrid abutment design.

Indications for Use

Indicated for partially or fully edentulous patients requiring single cement-retained restorations supported by endosseous dental implants. Specific restriction: Straumann Bone Level 3.3 L Ti base limited to single lateral incisors (maxilla) and lateral/central incisors (mandible).

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

• Sirona Dental CAD/CAM System (K111421)
• IPS e.max CAD (K051705)
• IPS e.max Press Abutment Solutions (K120053)
• IPS e.max Press Abutment Solutions (K124008)

Reference Devices

• Nobel Biocare Replace (K020646)
• Nobel Biocare Activem (K071370)
• Straumann Bone Level (K053088)
• Straumann Bone Level (K062129)
• Straumann Bone Level (K060958)
• Biomet 3i Osseotite (K980549)
• Biomet 3i Certain (K014235)

Submission Summary (Full Text)

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#### 510(K) SUMMARY (revised)

IPS e.max® CAD Abutment Solutions

| Contact: | Donna Marie Hartnett, Director QA/Regulatory Affairs |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent. 175 Pineview Drive, Amherst, NY 14228<br>[phone] |
| Date Prepared: | October 18, 2013 |
| Proprietary Name: | IPS e.max® CAD Abutment Solutions |
| Classification Name: | Abutment, Implant, Dental Endosseous (872.3630) |
| Predicate Devices: | Sirona Dental CAD/CAM System (K111421)<br>IPS e.max CAD (K051705)<br>IPS e.max Press Abutment Solutions (K120053 and K124008) |

Device Description: IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. Titanium bases are a premanufactured prosthetic component directly connected to dedicated endosseous dental implants. The Titanium base is used for adhesion to mesostructures to restore function and esthetics in the oral cavity. IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already include in the shipped block. Connection geometries fit select Titanium Bases marketed by Straumann, Nobel Biocare and Biomet 31 as identified in the Intended Use section. The mesostructure is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown as designed by the trained professional using the Sirona inLab and Cerec SW 4.2 (or higher) software.. The device serves as the esthetic mesostructure which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

Predicate Device: The predicate device to which IPS e.max® CAD Abutment Solutions has been compared is Sirona Dental CAD/CAM System(K111421). For this application, IPS e.max® CAD Abutment Solutions has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that IPS e.max® CAD Abutment Solutions is substantially equivalent to the predicate device.

510K Summary 5-1

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### 510(K) SUMMARY (revised)

IPS e.max® CAD Abutment Solutions

Intended Use:

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts:

IPS e.max CAD ceramic structure,

Ti base and

CAD/CAM software

The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, Ti bases and CAD/CAM systems are shown below:

Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088,), Biomet 3i Certain (K014235)

| Titanium bases: | | |
|-----------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | and the contract and the contract and the comments of the property of the province of the supportunity | Company of the country of the county of the county of |

| Implant<br>manufacturer | Implant System | Implant<br>Diameter<br>(mm) | TiBase | Sirona Ref. | Interface<br>size |
|-------------------------|-----------------|-----------------------------|----------|-------------|-------------------|
| Nobel Biocare | Replace NP | 3.5 | NBRS 3.5 | 6282474 | L |
| Nobel Biocare | Replace RP | 4.3 | NBRS 4.3 | 6282482 | L |
| Nobel Biocare | Replace WP | 5.0 | NBRS 5.0 | 6282490 | L |
| Nobel Biocare | Replace 6.0 | 6.0 | NBRS 6.0 | 6282508 | L |
| Nobel Biocare | Nobel Active NP | 3.5 | NB A 4.5 | 6208188 | L |
| Nobel Biocare | Nobel Active RP | 4.3 / 5.0 | NB A 5.0 | 6208253 | L |
| Straumann | Bone Level NC | 3.3 | S BL 3.3 | 6308154 | L |
| Straumann | Bone Level RC | 4.1 / 4.8 | S BL 4.1 | 6308337 | L |
| Biomet 3i | Certain | 3.4 | B C 3.4 | 6308048 | S |
| Biomet 3i | Certain | 4.1 | B C 4.1 | 6308097 | L |
| Biomet 3i | Certain | 5.0 | B C 5.0 | 6308121 | L |

For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

Material Composition: The device is composed or proprietary lithium disilicate (Li Si 2) dental ceramic and is identical in composition to IPS e/max CAD (K051705).

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## 510(K) SUMMARY (revised)

IPS e.max® CAD Abutment Solutions

Technological Characteristics: The device design, i.e. delivery form, and intended use of IPS e.max CAD Abutment Solutions and the predicate device are the same. The materials comply with ISO 6872:2008 for Dental Ceramics. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.

Scientific Concept: The underlying scientific concept is the use of an already introduced technology of a titanium base abutment combined with individually CAD/CAM fabricated ceramic prosthetics made from lithium disilicate, a material proven to be suitable for safe and effective dental restoratives.

Testing Summary: According to FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments" may 12, 2004, fatigue testing has been performed for angled abutments.

Physical properties of IPS e.max CAD:

- CTE (100°C 500°C) 10.5 ± 0.5 10 %K ー > 360 MPa (Test Method ISO 6872) -Flexural strength (Biaxial) ≥ 2.0 MPa moss (Test Method ISO 6872) Fracture toughness -Chemical solubility < 50 []g/cm2 (Test Method ISO 6872) --Crystallization temperature 840 - 850°C
Conclusion: IPS e.max CAD Abutment Solutions is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with outstretched wings, with three wavy lines extending from the eagle's body.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 31, 2013

Ivoclar Vivadent AG C/O Donna Hartnett Director of Quality Affairs/Regulatory Affairs Ivoclar Vivadent, Incorporation 175 Pineview Dr. AMHERST NY. 14228

Re: K132209

Trade/Device Name: IPS e.max® CAD Abutment Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: August 6, 2013 Received: August 7, 2013

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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Page 2 - Ms. Hartnett

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MarylSBuner-S

Kwame Ulmer, MS 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): K132209

Device Name: IPS e.max® CAD Abutment Solutions

#### Indications For Use:

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts:

IPS e.max CAD mesostructure, Ti base and CAD/CAM software.

The IPS e.max CAD mesostructure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, Ti bases and CAD/CAM systems are shown below:

Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549)

CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above

| Implant manufacturer | Implant System | Implant Diameter (mm) | TiBase | Sirona Ref. | Interface size |
|----------------------|-----------------|-----------------------|----------|-------------|----------------|
| Nobel Biocare | Replace NP | 3.5 | NBRS 3.5 | 6282474 | L |
| Nobel Biocare | Replace RP | 4.3 | NBRS 4.3 | 6282482 | L |
| Nobel Biocare | Replace WP | 5.0 | NBRS 5.0 | 6282490 | L |
| Nobel Biocare | Replace 6.0 | 6.0 | NBRS 6.0 | 6282508 | L |
| Nobel Biocare | Nobel Active NP | 3.5 | NB A 4.5 | 6208188 | L |
| Nobel Biocare | Nobel Active RP | 4.3 / 5.0 | NB A 5.0 | 6208253 | L |
| Straumann | Bone Level NC | 3.3 | S BL 3.3 | 6308154 | L |
| Straumann | Bone Level RC | 4.1 / 4.8 | S BL 4.1 | 6308337 | L |
| Biomet 3i | Certain | 3.4 | B C 3.4 | 6308048 | S |
| Biomet 3i | Certain | 4.1 | B C 4.1 | 6308097 | L |
| Biomet 3i | Certain | 5.0 | B C 5.0 | 6308121 | L |

Titanium bases:

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 2

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For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

Prescription Use __ _ _ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Andre 2013.10.30

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 2