IPS INLINE POM SYSTEM

K071848 · Ivoclar Vivadent, Inc. · EIH · Aug 30, 2007 · Dental

Device Facts

• Record ID: K071848
• Device Name: IPS INLINE POM SYSTEM
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EIH · Dental
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer; mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10°K-25-500 °C The material is contraindicated for: - Pressing over metal frameworks beyond the CTE range - Very deep sub-gingival preparations - Patients with substantially reduced residual dentition - Patients with bruxism and - Use with alloys with a silver content of more than 10% Other limitations of use: - Combination with any other ceramic materials - Pressing IPS InLine PoM ingots thinner than 0.8mm - Pressing of IPS InLine PoM ingots without a metal framework - Layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials - Pressing over metal frameworks that do not exhibit the required minimum thickness for copings or connectors.

Device Story

IPS InLine PoM is a leucite-based ceramic system for dental restoration fabrication using a press-on technique. Process involves lost wax method: metal framework waxed, invested, and burned out; ductile ceramic ingot pressed into hollow space via press furnace. System components include porcelain opaquer, ingots, touch-up/add-on powders, and shade/stain/glaze pastes. Used in dental laboratories by technicians to create crowns and bridges. Final restorations are placed by dentists to restore tooth function and aesthetics. Benefits include anatomical restoration of posterior teeth.

Clinical Evidence

Bench testing only. The device was designed and tested in accordance with ISO 6872 (Dental Ceramic) and ISO 9693 (Metal-ceramic dental restorative systems). No clinical data provided.

Technological Characteristics

Leucite-ceramic material system. Processing via press furnace (lost wax technique). Designed to ISO 6872 and ISO 9693 standards. Compatible with metal frameworks having a CTE range of 13.8-14.5 10^-6/K (25-500°C).

Indications for Use

Indicated for fabrication of fully anatomical dental restorations on metal crown and bridge frameworks, primarily in the posterior region. Contraindicated for patients with bruxism, substantially reduced residual dentition, very deep sub-gingival preparations, or use with alloys containing >10% silver or outside the 13.8-14.5 CTE range.

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

• PTM System by Dentsply (K041335)

Submission Summary (Full Text)

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K071848

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst. New York 14228 el: 800-533-716-691-0010 xtension: 2260 x: 716-691- 2294 Donna. [e-mail]

Image /page/0/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo is black and white and features the company name in a bold, sans-serif font. Above the name is a semi-circle of dots and squares. Below the name is the tagline "passion vision innovation" in a smaller font.

**passion vision innovation**

## 510(K) SUMMARY

AUG 3 0 2007

| Contact: | Donna Marie Hartnett |
|----------|----------------------|
|----------|----------------------|

Date Prepared: July 3, 2007

Trade Name: IPS InLine PoM System

Classification Name: Porcelain Powder for Clinical Use (872.6660)

Predicate Devices: PTM System by Dentsply (K041335)

Device Description: IPS InLine PoM is a dental porcelain system composed of a leucite-ceramic which utilizes a press-on technique for dental restoration fabrication. The restoration is processed according to the lost wax technique. The opaqued metal framework is first waxed up in the desired shape and function and invested. After investment and burning out of the wax, the ductile ceramic - IPS InLine PoM ingot, is pressed into the previously created hollow space by means of a press furnace. After divesting the pressed objects, they are individually characterized using the new Shade/Stain and Glaze materials intended to be marketed with this System.

The InLine PoM System consists of a porcelain Opaquer, Porcelain Ingots, Touch up and Add-On Porcelain powders, and Shade, Stain and Glaze porcelain pastes with accompanying liquids.

Intended Use:

IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer; mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10°K-25-500 °C

The material is contraindicated for:

- Pressing over metal frameworks beyond the CTE range 볼
- Very deep sub-gingival preparations I
- 트 Patients with substantially reduced residual dentition
- 트 Patients with bruxism and
- Use with alloys with a silver content of more than 10% 트

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Other limitations of use:

- Combination with any other ceramic materials 트
- . Pressing IPS InLine PoM ingots thinner than 0.8mm
- Pressing of IPS InLine PoM ingots without a metal framework 트
- Layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials
- . Pressing over metal frameworks that do not exhibit the required minimum thickness for copings or connectors.

Technological Characteristics: The IPS InLine PoM System represents a modification to the IPS Classic and IPS InLine porcelain systems by Ivoclar Vivadent. Changes have been made in the device's formulation and processing technique.

IPS InLine PoM was designed and tested in accordance with ISO 6872 for Dental Ceramic and ISO 9693 for Metal-ceramic dental restorative systems.

All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact safety or efficacy.

We believe that the prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the IPS InLine PoM System for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it. The caduceus is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

AUG 3 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Donna Marie Hartnett Director of Quality Assurance/Regulatory Affairs and Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K071848

Trade/Device Name: IPS InLine PoM System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 28, 2007 Received: July 12, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). "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/cdrh/industry/support/index.html.

Sincerely yours,

Syille Y. Michie Ould.

Chiu Lin, Ph.D. 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

510(k) Number (if known):

Device Name: IPS InLine PoM System Indications For Use:

IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer, mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10 °K 1 25-500 °C

107 1848

The material is contraindicated for:

- Pressing over metal frameworks beyond the CTE range 에
- Very deep sub-gingival preparations ■
- Patients with substantially reduced residual dentition l
- 이 Patients with bruxism and
- D Use with alloys with a silver content of more than 10%

Other limitations of use:

- Combination with any other ceramic materials 제
- Pressing IPS InLine PoM ingots thinner than 0.8mm b
- Pressing of IPS InLine PoM ingots without a metal framework 동
- Layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, 를 Impulse and Gingiva materials
- Pressing over metal frameworks that do not exhibit the required I minimum thickness for copings or connectors.

Prescription Use V 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Rumpe

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

510(k) Number: