CRISTOBAL

K980018 · Newave Medical, Inc. · EBF · May 19, 1998 · Dental

Device Facts

• Record ID: K980018
• Device Name: CRISTOBAL
• Applicant: Newave Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: May 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To construct cosmetic prosthetic dental restoratives for use in fixed restorations with or without metal frameworks to include: - single crowns, - telescope crowns, - conus crowns, - bridges, - Maryland bridges, - bridges on implants, - inlays, - onlays - facettes (laminate veneers), and - restorations.

Device Story

CRISTOBAL is a layered composite restorative dental material; composed of silanized barium borosilicate particles (74.2 weight percent) in a matrix of Bis-GMA, TEDMA, and UDDMA. Device functions as a tooth-colored restorative material for fixed prosthetics; provides wear resistance, flexural strength, and damage resistance. Applied by dental professionals in a clinical setting to construct crowns, bridges, inlays, onlays, and veneers. Material requires light curing for complete polymerization; radio-opaque properties allow for functional and mechanical longevity. Output is a prosthetic restoration providing natural tooth aesthetics and occlusal function; benefits patient through durable, cosmetic tooth replacement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing comparing physical and mechanical properties, including flexural strength, modulus of flexibility, compressive strength, Vickers hardness, abrasion, and polymerization shrinkage against predicate devices.

Technological Characteristics

Composite restorative material; composition: silanized barium borosilicate particles (77% by weight), Bis-GMA, TEDMA, UDDMA matrix. Light-cured polymerization. Radio-opaque. Mechanical properties: 155 MPa flexural strength, 8500 MPa flexural modulus, 670 N/mm² Vickers hardness. Form factor: layered composite material for dental prosthetics.

Indications for Use

Indicated for patients requiring fixed cosmetic prosthetic dental restorations, including single crowns, telescope/conus crowns, bridges (with or without metal frameworks), Maryland bridges, implant-supported bridges, inlays, onlays, and laminate veneers.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Kulzer Dentacolor (K831215)
• Heraeus Kulzer ArtGlass (K954115)

Submission Summary (Full Text)

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# MAY | 9 1998

#### SMDA Summary of Safety and Effectiveness - "510(k) Summary" 8.

- A. Submittor Information
Newave Medical Inc. c/o Interactive Consulting Ins. 70 Walnut Street Wellesley, MA 02181

Telephone: [phone]

Jean-Luc Boulnois Contact Person: Secretary

December 26, 1997 Date Prepared:

#### B. Device Identification

Common/Usual Name Proprietary Name:

Glass Strength Restorative Dental Materials CRISTOBAL

#### C. Identification of Predicate Device(s)

CRISTOBAL is substantially equivalent to the following previously cleared and currently marketing devices:

> Kulzer Dentacolor (K831215) Heraeus Kulzer ArtGlass (K954115)

#### D. Device Description

CRISTOBAL consists of a series of layered composite restorative glass strength materials, combining the benefit of porcelain, composite and dental alloys, whose combined properties of wear resistance, flexural strength, maximum compressive strength and bulk modulus, make it suitable for all types of fixed cosmetic prosthetic restorations. CRISTOBAL offers the patient a tooth colored occlusal surface with the feeling of natural teeth.

CRISTOBAL is subject to complete polymerization for optimal reactions of the various materials. Due to the fact that the light curing material of CRISTOBAL is radioand its matrix has a very high content in inorganic particles (barium opaque. borosilicate), it allows for the production of fixed prostheses with functional, mechanical, and cosmetic longevity.

CRISTOBAL is composed of silanized barium borosilicate particles, a non-fracturable filler material, which are closely packed (74.2 weight percent) providing optimal silanization and cohesion of glass thereby ensuring protection against fracture together, with strong resistance to damage. With the matrix of Bis-GMA, TEDMA and UDDMA, these elastic memory properties also ensure damage resistance.

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## E. Substantial Equivalence

The technical characteristics of CRISTOBAL are almost identical to those of the Heraeus Kulzer ArtGlass and the Kulzer Dentacolor. Refer to Table A for a comparison of these predicate devices. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems, do not affect the relative safety or effectiveness of the CRISTOBAL materials.

The Newave Medical CRISTOBAL, the Heraeus Kulzer ArtGlass, and the Kulzer Dentacolor are intended to be used for construction of cosmetic prosthetic restoratives for use in fixed restorations, with or without metal frameworks for:

- single crowns, .
- telescope crowns, .
- conus crowns, .
- bridges, (with metal-frame) ●
- Maryland bridges, .
- bridges on implants, .
- inlays, .
- onlays .
- facettes (laminate veneers), and ●
- restorations. .

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TABLE A Comparison Table: Restorative Dental Materials

ﺃﺳﺴﻪ ﺍﻟ

| Manufacturer: | Kulzer | Heraeus Kulzer | Newave Medical Inc |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Model<br>K-Number | DENTACOLOR<br>K831215 | ARTGLASS<br>K954115 | CRISTOBAL |
| Class | II | II | Request II |
| Properties of Strength: | | | |
| Bending/Flexural (MPa)<br>Modulus Flexibility (MPa)<br>Comprehensive (MPa)<br>Vickers-Hardness (N/mm²)<br>Fracture Damage during Vickers Hardness<br>Tests (mm²)<br>Abrasion (µm/year)<br>Bulk Modulus NFT 51101 (MPa)<br>Water Solubility (ug/mm²) | 70-75<br>3300 - 3500<br>350<br>400<br>Not Available<br>Not Available<br>Not Available<br>1 | 120<br>9 000<br>Not Available<br>590<br>Not Available<br>Good<br>Not Available<br>0.5 | 155<br>8 500<br>350<br>670<br>0,245<br><8<br>4 084<br>-10-2 |
| Chemical Composition | | | |
| Type of Filler Material<br>Total Mineral Filler Content by Weight (%) | Pyrogenic Silicon Dioxide<br>51 | Microfine Glass Particles<br>72 | Barium Borosilicate<br>77 |
| Other: | | | |
| Glazing Technique<br>Polymerization Shrinkage (%)<br>Shade Stability (ΔE) | Mechanical Polishing<br>0.16<br>~3 | Mechanical Polishing<br>Negligible<br>2 | Mechanical Polishing<br>0.12<br>High |

..............................................................................................................................................................................

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### Manufacturer:

Clinicals:

Clinical Claims With or Without Metal-Frames Kulzer DENTACOLOR

Crowns

Bridges

Heraeus Kulzer ARTGLASS

Veneers

Inlays

Onlays

Crowns

Bridges

Maryland Bridges

Implant Supported Restorations

Telescope and Conus Crowns

Attachment retained prosthesis

ﺗﺤﺼﻴﻠﻴﺔ - ﺗ

Newave Medical Inc. CRISTOBAL

ﺎ ﺍﻟﻤﺴﺘﻌﻤﻞ ﻣ

Single Crowns Telescope Crowns Conus Crowns Bridges (with metal-frame) Maryland Bridges, Bridges on Implants Inlays Onlays Facettes (Laminate veneers) Restorations

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | 9 1998

Newave Medical, Incorporated C/O Ms. Jacqueline E. Masse Senior Consultant 70 Walnut Street Wellesley, Massachusetts 02181

Re : K980018 Trade Name: CRISTOBAL Regulatory Class: II Product Code: EBF Dated: April 2, 1998 Received: April 3, 1998

Dear Ms. Masse:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895.- A----. substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Masse

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timo ay A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K980018

CRISTOBAL Device Name:

Indications For Use:

To construct cosmetic prosthetic dental restoratives for use in fixed restorations with or without metal frameworks to include:

- single crowns,
- telescope crowns,
- conus crowns,
- bridges,
- Maryland bridges,
- bridges on implants,
- inlays,
- onlays
- facettes (laminate veneers), and
- restorations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runger
Division Sign-Off
Division of Dental

Division of Dental, d General Hospital

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ----------------------------------------------------------------------------------

(Optional Format 1-2-96)