IPS E.MAX PRESS - ABUTMENT SOLUTIONS

K120053 · Ivoclar Vivadent, AG · NHA · Oct 18, 2012 · Dental

Device Facts

• Record ID: K120053
• Device Name: IPS E.MAX PRESS - ABUTMENT SOLUTIONS
• Applicant: Ivoclar Vivadent, AG
• Product Code: NHA · Dental
• Decision Date: Oct 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

IPS e.max® Press Abutment Solutions is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations. IPS e.max Press Abutment Solutions is recommended for the fabrication of: - Hybrid abutments for single-tooth restorations - Hybrid abutment crowns for restorations - The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions.

Device Story

IPS e.max Press Abutment Solutions consists of lithium disilicate glass-ceramic components designed for fabrication of hybrid abutments and hybrid abutment crowns. Device functions as interface between dental implant and final restoration; utilizes compatible titanium (Ti) bases for connection to specific implant systems (e.g., Straumann Bone Level). Fabricated by dental technicians in laboratory settings; final restoration cemented to Ti base. Provides aesthetic, patient-specific support for single or multiple-unit dental prostheses in edentulous mandibles and maxillae.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Lithium disilicate glass-ceramic. Form factor: Custom-fabricated hybrid abutments and hybrid abutment crowns. Connectivity: Mechanical interface with compatible titanium (Ti) bases. Sterilization: Provided non-sterile; intended for laboratory processing and subsequent clinical cementation.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit cement-retained restorations supported by hybrid abutments or hybrid abutment crowns.

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

• Straumann Bone Level RC (K062129)
• RC Cementable abutment (K072071)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 8 2012

Ivoclar Vivadent AG C/O Ms. Donna Marie Hartnett Director of Quality Assurance / Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K120053

Trade/Device Name: IPS e.max® Press - Abutment Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, EIH Dated: September 28, 2012 Received: October 2, 2012

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.

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## Page 2- Ms. Hartnett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hi for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K 170053 510(k) Number (if known):

Device Name: IPS e.max® Press - Abutment Solutions

Indications For Use:

IPS e.max® Press Abutment Solutions is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained . restorations.

IPS e.max Press Abutment Solutions is recommended for the fabrication of:

- Hybrid abutments for single-tooth restorations •
- Hybrid abutment crowns for restorations -

The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions.

| Implant manufacture | Implant system, diameter | Compatible Ti base<br>(abutment), dimensions<br>diameter = D<br>gingiva height = GH<br>height = HTi |
|---------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Straumann® | Bone Level RC<br>Ø 4.1 mm or Ø 4.8 mm<br>510K K062129 | RC Cementable abutment<br>D 5.0-6.5 mm<br>GH 1.0-3.0 mm<br>HTi 4.0-5.5 mm<br>510K K072071 |

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

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

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| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |

| 510(k) Number: | K120053 |
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