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.

AI/ML Overview

Despite the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, the provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific performance thresholds.

Instead, the document is a 510(k) Pre-market Notification Summary for a dental restorative material called CRISTOBAL. The primary purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to present a standalone performance study against pre-defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to address the points based on the available information, highlighting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not define specific "acceptance criteria" against which CRISTOBAL was tested in a dedicated study. Instead, it compares CRISTOBAL's properties to those of two predicate devices to demonstrate substantial equivalence.

Property	Predicate Device 1 (Kulzer DENTACOLOR)	Predicate Device 2 (Heraeus Kulzer ARTGLASS)	CRISTOBAL (Reported Performance)
Bending/Flexural (MPa)	70-75	120	155
Modulus Flexibility (MPa)	3300 - 3500	9 000	8 500
Comprehensive (MPa)	350	Not Available	350
Vickers-Hardness (N/mm²)	400	590	670
Fracture Damage during Vickers Hardness Tests (mm²)	Not Available	Not Available	0.245
Abrasion (µm/year)	Not Available	Good	< 8
Bulk Modulus NFT 51101 (MPa)	Not Available	Not Available	4 084
Water Solubility (ug/mm²)	1	0.5	-10-2 (0.01)
Type of Filler Material	Pyrogenic Silicon Dioxide	Microfine Glass Particles	Barium Borosilicate
Total Mineral Filler Content by Weight (%)	51	72	77
Glazing Technique	Mechanical Polishing	Mechanical Polishing	Mechanical Polishing
Polymerization Shrinkage (%)	0.16	Negligible	0.12
Shade Stability (ΔE)	~3	2	High

Note: The comparison in the document aims to show CRISTOBAL is "substantially equivalent" in properties, often performing comparably or better than the predicates. There are no explicit "acceptance criteria" values provided in this table.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document does not describe a clinical or lab "test set" in the traditional sense of a study designed to meet acceptance criteria. The data presented are material property values, likely derived from standard material testing methods, but the sample sizes for these tests are not provided.
Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether the data is retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This document does not describe a study involving expert assessment or "ground truth" establishment in the context of clinical or image-based diagnostics. The data are material properties, not interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as no expert-based "test set" requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a material science submission, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. No algorithm or AI component is described in the context of this dental material.

7. Type of Ground Truth Used

Not applicable in the conventional sense. The "ground truth" for the reported material properties would be the physical measurements obtained through standardized material testing methods. No "expert consensus," "pathology," or "outcomes data" is mentioned as a ground truth for the material properties.

8. Sample Size for the Training Set

Not applicable. This document is about a physical dental material; there is no "training set" as it would apply to machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set involved.

Summary

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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: 617 239-8108

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

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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
ModelK-Number	DENTACOLORK831215	ARTGLASSK954115	CRISTOBAL
Class	II	II	Request II
Properties of Strength:
Bending/Flexural (MPa)Modulus Flexibility (MPa)Comprehensive (MPa)Vickers-Hardness (N/mm²)Fracture Damage during Vickers HardnessTests (mm²)Abrasion (µm/year)Bulk Modulus NFT 51101 (MPa)Water Solubility (ug/mm²)	70-753300 - 3500350400Not AvailableNot AvailableNot Available1	1209 000Not Available590Not AvailableGoodNot Available0.5	1558 5003506700,245<84 084-10-2
Chemical Composition
Type of Filler MaterialTotal Mineral Filler Content by Weight (%)	Pyrogenic Silicon Dioxide51	Microfine Glass Particles72	Barium Borosilicate77
Other:
Glazing TechniquePolymerization Shrinkage (%)Shade Stability (ΔE)	Mechanical Polishing0.16~3	Mechanical PolishingNegligible2	Mechanical Polishing0.12High

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

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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

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

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.