NOBELPROCERA IPS E.MAX CROWN

K100512 · Nobel Biocare AB · EIH · Aug 20, 2010 · Dental

Device Facts

• Record ID: K100512
• Device Name: NOBELPROCERA IPS E.MAX CROWN
• Applicant: Nobel Biocare AB
• Product Code: EIH · Dental
• Decision Date: Aug 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelProcera IPS e.max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.

Device Story

NobelProcera IPS e.max Crown is a lithium disilicate glass-ceramic core superstructure for dental crowns. Fabrication involves either traditional wax-up or CAD design software. Wax-up designs are scanned at a laboratory; CAD designs are created digitally. Design data is transmitted to a Nobel Biocare manufacturing facility, where CAM techniques produce the core. The finished core is returned to the laboratory for final finishing. Used in dental clinics/laboratories by dental professionals to restore patient chewing function. Benefits include customized prosthetic fit and material strength for mastication.

Clinical Evidence

No clinical data. Safety and effectiveness supported by non-clinical mechanical testing, including ageing, biaxial (ISO 6872), static, and dynamic load tests to verify strength against mastication forces.

Technological Characteristics

Material: Lithium disilicate glass-ceramic. Fabrication: CAD/CAM or wax-up/scan. Energy: CAM manufacturing. Connectivity: Electronic transmission of design data to manufacturing facility. Standards: Biaxial testing per ISO 6872.

Indications for Use

Indicated for partially edentulous patients requiring prosthetic rehabilitation via crowns cemented to natural or artificial tooth abutments.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Procera Copings and Pontic (K032562)
• IPS e.max CAD/IPS e.max Zircad (K051705)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness 1.4

AUG 2 0 2010

| Submitted by: | Herbert Crane<br>Director, Global Requlatory Affairs |
|----------------------------------------|----------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date of Submission: | February 19, 2010 |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660)<br>Product code EIH |
| Trade or Proprietary<br>or Model Name: | NobelProcera IPS e.max Crown |
| Legally Marketed Device(s): | Procera Copings and Pontic (K032562)<br>IPS e.max CAD/IPS e.max Zircad (K051705) |

#### Device Description:

イン

NobelProcera IPS e.max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium disilicate glass-ceramic using a wax-up or CAD design technique.

The Nobel Biocare IPS e.max CAD core superstructure can be designed using traditional wax-up t no nove or using Nobel Biocare crown design software. The core superstructure can be designed using the final anatomic shape or a cut-back technique. Wax-up designs are scanned at the laboratory. Both scanned wax-up and CAD designed core superstructure design information is transmitted electronically to the Nobel Biocare manufacturing facility. The core superstructures are manufactured using CAM techniques and delivered to the laboratory for finishing.

#### Indications for Use:

The NobelProcera IPS e max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.

#### Non-Clinical Testing

Nobel Biocare has performed mechanical testing of the e.max material including ageing, biaxial (ISO 6872), static, and dynamic load tests to ensure the product will be strong enough to withstand the anticipated mastication forces.

#### Clinical Testing

Non-clinical test data was used to support the decision of safety and effectiveness.

### Conclusions

The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices.

Nobel Biocare USA Traditional 510(k) Notification NobelProcera IPS e.max Crown February 2010

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Substantial Equivalence Comparison to Predicate Devices

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| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical Site | Nobel Procera IPS e.max<br>Crown | Procera Copings and Pontic<br>(K032562) | IPS e.max CAD/IPS e.max Zircad<br>(K051705) |
| | - Oral Cavity | - Oral Cavity | - Oral Cavity |
| Material | Lithium disilicate ceramic<br>(IPS e.max CAD blocks) | Aluminum oxide<br>- Zirconium oxide | Lithium disilicate ceramic<br>- Zirconium oxide |
| Indications for Use | The Nobel Procera IPS e.max<br>Crown is indicated for use as<br>core structures of crowns<br>that will be cemented to<br>natural or artificial tooth<br>abutments in the treatment of<br>partially edentulous patients<br>as an aid in prosthetic<br>rehabilitation. | Nobel Biocare's Procera®<br>Copings and Pontic are indicated<br>for use as core structures of an<br>artificial prosthesis, i.e. a three-<br>unit bridge, for partially<br>edentulous patients in the need of<br>prosthetic oral reconstruction in<br>order to restore chewing function.<br><br>The Pontic is indicated as the<br>core structure of the center unit<br>and the Copings are indicated as<br>the core structures of the two side<br>crowns, thereby forming the<br>three-unit bridge.<br><br>- The Copings are also<br>indicated for use as single<br>crowns that will be cemented<br>to a natural or artificial tooth<br>abutment in the treatment of<br>partially edentulous patients<br>in order to restore chewing<br>function. | IPS e.max CAD is a CAD/CAM<br>machinable glass ceramic based<br>on lithium disilicate for the<br>preparation of full ceramic<br>crowns, inlays, onlays, and full<br>ceramic 3-unit anterior bridges.<br><br>IPS e.max ZirCAD consists of<br>machinable zirconia blocks for<br>the preparation of full ceramic<br>crowns, onlays and 3- and 4-unit<br>bridges and inlay bridges<br>(anterior and molar). |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Nobel Biocare AB C/O Mr. Herbert Crane Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

# AUG 2 0 2010

Re: K100512

Trade/Device Name: NobelProcera IPS e.max Crown Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: July 27, 2010 Received: July 28, 2010

Dear Mr. Crane:

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 ffor 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 mav, 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- Mr. Crane

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.

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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K100512

## Indications for Use

510(k) Number (if known):

Device Name: NobelProcera IPS e.max Crown

Indications For Use:

The NobelProcera IPS e.max Crown isindicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kio Muly Cm MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1

510(k) Number: K100512