DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, II, and V cavities.

Device Description

DoxaDent™ is a dental ceramic composed of a calcium aluminate cement and oxides, i.e., silica and zirconium oxide, and iron oxide colorants, as a filler material, in a blend of fine irregularly shaped particles ranging from 0.5 to 5 um in diameter and microfine particles having a diameter of 0.02 to 0.2 um. Trace concentrations of iron oxide additives (< 0.05% w/w) and alkali salt accelerators (LiCl, < 0.1% w/w) are included to provide for coloring and to control the rate of hydration, respectively.

AI/ML Overview

The provided text is a 510(k) summary for Doxa Certex AB's DoxaDent™, a dental ceramic. The document describes the device, its intended use, technological characteristics, and predicate devices. It also lists performance tests conducted but does not explicitly define acceptance criteria for these tests, nor does it provide detailed study results that explicitly prove the device meets pre-defined acceptance criteria in a quantitative manner.

Therefore, I cannot fully complete the table and answer all questions as requested due to the absence of this information in the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists performance tests conducted, but does not specify the acceptance criteria used for each test. It only states, "In all instances, the DoxaDent™ functioned as intended and performance observed was as expected." This general statement prevents a quantitative comparison against specific criteria.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Specific passing levels for flexural strength, etc. are not provided.	Functioned as intended and performance observed was as expected for all tests.
Flexural properties	No specific values given.
Shade	No specific values given.
Color stability	No specific values given.
Radio-opacity	No specific values given.
Working and setting times	No specific values given.
Marginal adaptation	No specific values given.
Microstructure	No specific description given.
Compressive strength	No specific values given.
Biocompatibility and chemical stability	Submitted for publication to the 2001 IADR meeting.
Acid erosion	No specific values given, but tested according to EN 29917:1994/ISO 9917:1991.
Dimensional stability	No specific values given.
Wear testing	No specific values given.
Leakage (Leaching) and pH	No specific values given.
Electrical pulp sensitivity test	No specific values given.
Hardness	No specific values given.
Clinical X-ray analysis of implants	Evaluation of DoxaDent implants.
Clinical gingival reactions and plaque formation	Evaluation of gingival reactions and plaque formation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified in the provided text for any of the performance or clinical tests.
Data Provenance: The performance tests were conducted by Doxa Certex AB. Doxa Certex AB is located in Uppsala, Sweden, suggesting the data originated from Sweden. The document does not specify if the studies were retrospective or prospective, though clinical evaluations often imply prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Experts and Qualifications: Not specified in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not specified in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, this device is a dental ceramic material, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the physical/chemical tests (flexural properties, hardness, etc.): The ground truth would be established by standardized testing methodologies and measurements, comparing against established material science parameters or industry standards (e.g., ISO, EN). The text mentions specific standards like EN 29917:1994/ISO 9917:1991 for acid erosion.
For the "Study on the marginal adaptation of DoxaDent™ in extracted teeth" and "X-ray analysis of DoxaDent implants and evaluation of gingival reactions and plaque formation": The ground truth would likely be based on direct observation, imaging, and potentially histological analysis by qualified dental professionals, though this is not explicitly stated.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a medical device material, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Training Set Ground Truth Establishment: Not applicable. This is a medical device material, not a machine learning algorithm.

Summary

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K011839

510(k) SUMMARY

Doxa Certex AB's DoxaDent™

JAN 1 7 2002

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Doxa Certex AB Axel Johanssons gata 4 - 6, SE-75451 Uppsala, Sweden +46-18-4782000 Phone: Facsimile: +46-18-4782071

Contact Person: Nils-Otto Ahnfelt

Date Prepared: June 12, 2001

Name of Device and Name/Address of Sponsor

DoxaDent™

Doxa Certex AB Axel Johanssons gata 4 - 6 SE-75451 Uppsala, Sweden

Common or Usual Name

DoxaDent Dental Ceramic

Classification Name

Tooth Shade Resin Materials

Predicate Devices

Dentsply AP Dyract® Compomer dental composites
Bisco, Inc.'s PYRAMID™, ADVENT™, and RENEW™ dental composites
Coltene/Whaledent's Coltosol Temporary Endodontic Filling

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Intended Use/Indications for Use

Technological Characteristics and Substantial Equivalence

DoxaDent™ is substantially equivalent to a combination of Dentsply AP Dyract® Compomer, Bisco, Inc.'s PYRAMID™, ADVENT™, and RENEW™ dental composites, as well as Coltène/Whaledent's Coltosol Temporary Endodontic Filling. Any minor difference do not raises any new issues of safety or effectiveness.

Performance Data

The following performance test were conducted by Doxa Certex AB on the DoxaDent™:

· Flexural properties
◆ Shade
� Color stability
Radio-opacity ◆
Working and setting times �
Study on the marginal adaptation of � DoxaDent™ in extracted teeth
Microstructure of DoxaDent™ ◆ ◆
Determination of compressive strength
Some aspects of biocompatibility and chemical stability of a calcium-aluminate-hydrate-based dental restorative material, submitted for publication to the 2001 IADR meeting in Chiba, -Japan

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◆ Acid erosion by impinging jet technique according to EN 29917:1994/ISO 9917:1991 and Technical Corrigendum 1:1993 Dental waterbased cements
Dimensional stability �
♦ Wear testing
◆ Leakage (Leaching) and pH
Electrical pulp sensitivity test ◆ ◆
♦ Hardness

In all instances, the DoxaDent™ functioned as intended and performance observed was as expected.

Clinical Data

DoxaCertex AB performed X-ray analysis of DoxaDent implants and evaluation of gingival reactions and plaque formation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Doxa Certex AB C/O Mr. Jonathan S. Kahan Hogan and Harton 555 13th Street Northwest Washington, District of Columbia 20004-1109

Re: K011839

Trade/Device Name: DoxaDent™ Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Materials Regulatory Class: II Product Code: EBF Dated: October 31, 2001 Received: October 31, 2001

Dear Mr. Kahan:

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.

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.

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Page 2 - Mr. Kahan

You must comply with ail the Act's requirements, including, but not limited to: registration r od intist comply with and 10 ; labeling (21 CFR Part 801); good manufacturing practice alle libang (2) 02 10 11 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 11ms letter will and will be rogen of 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally in the at (301) 594-4613 . 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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K011839 510(k) Number (if known):

DoxaDent™ Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _ (Optional Format 1-2-96)

wnges 'Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _

\\DC - 69389/1 - #1335262 v1

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.