(56 days)
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.
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.
The provided text describes a dental ceramic system, the IPS InLine PoM System, and mentions its development and testing according to specific ISO standards for dental ceramics and metal-ceramic dental restorative systems (ISO 6872 and ISO 9693). However, the document does not contain an acceptance criteria table, reported device performance data, or details about a study that would typically be described with the requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The document is a 510(k) summary for a premarket notification for a Class II medical device, indicating that the manufacturer believes the device is substantially equivalent to legally marketed predicate devices. The safety and effectiveness are supported by the prior use of components, similarity in formulations, and data provided regarding modifications.
Therefore, I cannot provide the requested information from the given text as it does not contain details of a clinical or performance study with the level of detail asked in your prompt.
Summary of missing information based on your request:
- Table of acceptance criteria and reported device performance: Not present. The document only states that the device was designed and tested in accordance with ISO 6872 and ISO 9693.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
- Adjudication method for the test set: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical dental material, not an AI algorithm.
- Type of ground truth used: Not present.
- Sample size for the training set: Not applicable/not present.
- How the ground truth for the training set was established: Not applicable/not present.
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Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst. New York 14228 el: 800-533-716-691-0010 xtension: 2260 x: 716-691- 2294 Donna. Hartnett@ivoclarvivadent.us.com
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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.