The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is intended to be used as a functional restoration for primary teeth, including for a badly decayed deciduous (baby) tooth, until the adult tooth erupts. It is not intended for permanent restoration. The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is indicated for use in infants, children, and adolescents.

Device Description

The EPI Ceramic Pediatric Preformed Crown is a temporary tooth restoration. The dental crown is a tooth-shaped "cap" that is placed over a tooth - covering the tooth to restore its shape and size, strength, and/or to improve its appearance. The preformed crowns are manufatured in specific sizes for a proper fit, which are contained within the range of sizes commonly available for existing preformed crowns. Sizing is exclusively determined by the dentist for their particular patient and the EPI crowns are not meant to undergo further manipulation by the dentist. The EPI Ceramic Pediatric Preformed Crown is secured within the patient's mouth using standard denal adhesion techniques. The crowns, when cemented into place, fully encase the entre visible portion of a tooth that lies at and above the gum line. The EPI Ceramic Pediatric Preformed Crown is made of Zirconia. Zirconia is a biologically inert, high-tech ceramic material (dental porcelain) intended for use in the construction of irentium oxide ceramic prosthetics. Because the EPI crowns are distributed in their final, finished form, there are no pellets, casting alloys, powders or auto mix systems that require firther manipulation by the dentist.

AI/ML Overview

The provided text is a 510(k) summary for the EZ-Pedo Inc. Ceramic Pediatric Preformed Crown. It details the device, its indications for use, and its substantial equivalence to predicate devices, but does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, etc.

The summary focuses on establishing substantial equivalence based on indications for use, technological characteristics, sizing, performance characteristics (general material adequacy), and processing compared to already legally marketed predicate devices.

Therefore, many of the requested details (acceptance criteria table, sample sizes for test/training, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods) are not present in this type of regulatory submission because they are typically relevant for AI/ML-driven devices or devices requiring extensive performance validation against specific endpoints. This device is a preformed dental crown, and its evaluation relies on material properties and comparison with existing crowns.

However, I can extract the information that is present according to your request format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary Statements)
Material Adequacy: Biologically inert, high-tech ceramic material suitable for long-term oral placement.	Made of Zirconia, a biologically inert, high-tech ceramic material.
Sizing: Preformed crowns in specific sizes within the range of commonly available existing preformed crowns.	Preformed crowns, sizes contained within sizes available for existing preformed crowns (e.g., NuSmile). Sizing exclusively determined by the dentist.
Technological Characteristics: Comparable to predicate devices.	Substantially equivalent to King Dental Corp Artificial Teeth & NuSmile Preformed Primary Crowns (preformed crowns) and Nobel Biocare Procera Bridge Zirconia & C5 Medical Werks CAD/CAM Blocks (Zirconia material, precision milled).
Performance Characteristics: Material adequate for intended use as a temporary restoration.	"Material adequate for its intended use" (general statement from non-clinical testing). Used as a functional restoration until adult tooth erupts.
Processing: No further manipulation required by the dentist after distribution.	Distributed in final, finished form; no pellets, casting alloys, powders, or auto mix systems. Precision milled.
Intended Use: Functional restoration for primary teeth in infants, children, and adolescents until adult tooth erupts.	Matches the stated Indications for Use.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document states "Non-clinical product testing was conducted on the preformed crown, including material adequate for its intended use," but does not detail the number of crowns tested or the methodology.
Data Provenance: Not specified beyond "Non-clinical product testing." No mention of country of origin or retrospective/prospective nature as this typically applies to clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/Not specified. This information is typically relevant for studies involving human interpretation (e.g., image reading) where ground truth is established by consensus. For a physical device like a dental crown, "ground truth" refers to objective physical and material properties (e.g., strength, biocompatibility), not expert consensus on an interpretation.
Qualifications of Experts: Not applicable/Not specified.

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

Adjudication Method: Not applicable. Adjudication methods are typically used for conflicting expert interpretations in diagnostic studies, which is not relevant for this device.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not for a preformed dental crown.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This refers to the performance of an algorithm without human intervention, which is not relevant for a physical dental device.

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

Type of Ground Truth: For this type of device, the "ground truth" would be objective specifications and material property testing results (e.g., biocompatibility testing, mechanical strength tests, dimensions). The summary only broadly states "material adequate for its intended use" from "Non-clinical product testing" without detailing the specific tests or their "ground truth" reference standards (e.g., ISO standards for dental materials).

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This concept is relevant for machine learning models, not for a physical dental crown.

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

Ground Truth Establishment for Training Set: Not applicable/Not specified.

Summary

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K091362

00018

JUN 2 9 2009

5. 510(K) SUMMARY

Applicant Name and Address:

EZ-Pedo Inc. 2350 Professional Drive Suite 200 Roseville, CA 95661

Establishment Registration Number: None at this time Device Name:

Classification: Classification Name: Product Code:

Ceramic Pediatric Preformed Crown 872.3330 Preformed Crown ELZ

Date Prepared: May 8, 2009

510(k) Contact Person and Phone Number:

Company: Dr. Jeffery P. Fisher Chief Executive Officer, EZ-Pedo Inc. (916) 768 -7592 (Phone) (916) 774-9437 (Fax)

Name and Address of Manufacturing Site

Company: EZ-Pedo Inc. . 2350 Professional Drive Suite 200 Roseville, CA 95661

Manufacturing Site Contact Person and Phone Number:

Elizabeth Weaver (916) 768 -7592

Predicate Devices:

The EPI Ceramic Pediatric Preformed Crown is claimed to be substantially equivalent to the following legally marketed predicate devices:

1. King Dental Corporation Artificial Teeth (Class I, K931162)
NuSmile Preformed Crowns Primary Crowns (Class I, 510(k) exempt) 2.
1. Procera Bridge Zirconia (K041283)
1. C5 Medical Werks ZirDent CAD/CAM Blocks (K081253)

General Description:

The EPI Ceramic Pediatric Preformed Crown is made of Zirconia. Zirconia is a biologically inert, high-tech ceramic material (dental porcelain) intended for use in the construction of irentium oxide ceramic prosthetics. Because the EPI crowns are distributed in their final, finished form, there are no pellets, casting alloys, powders or auto mix systems that require firther manipulation by the dentist.

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Indications for Use:

The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is intended to be used as a functional restoration, including for a badly decayed deciduous (baby) tooth, until the adult tooth erupts. The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is indicated for use in infants, children and adolescents.

Summary of Technical Characteristics

The technical characteristics of the EPI Ceramic Pediatric Preformed Crown are substantially equivalent to those of the King Dental Corporation Artifical Teeth (K931162) and the NuSmile Preformed Primary Crowns. Both devices are preformed crowns, and the sizes of the EPI crowns are contained within the sizes available for existing preformed crowns (i.e. NuSmile Preformed Crown - Primary Crowns, Class I devices, 510(k) exempt).

The technical characteristics of the EPI Ceramic Pediatric Preformed Crown are also substantially equivalent to those of the Nobel Biocare Procera Bridge Zirconia device (K041283) and the C5 Medical Werks CAD/CAM Blocks (K081253). All three devices are dental products intended for long term placement in the mouth, specifically contacting the gums (mucpus membrenee). All three devices are made of biologically inert Zirconia material. In addition, both the EPI crown and the Nobel Biocare Procera Bridge are precision milled from a single densely sintered Zirconia block. The EPI crown is precision milled directly from the C5 CAD/CAM blocks.

Summary of Non-Clinical Testing

Non-chincel product testing was conducted on the preformed crown, including material adequate for its intended use.

Conclusion

The EPI Ceramic Pediatric Preformed Crown is substantially equivalent with respect to the indications for use, technological characteristics, sizing, performance characteristics and processing to the following the legally marketed predicate devices:

I. King Dental Corporation Artificial Teeth (K931162)
NuSmile Preformed Crowns Primary Crowns (Class I, 510(k) exempt) 11.
============================================================================================================================================================================== Nobel Biocare Procera Bridge Zirconia (K041283)
IV. C5 Medical Werks CAD/CAM Blocks (K081253)

Section 5 -2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

JUN 29 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Jeffery Fisher CEO EZ-Pedo, Incorporated 2350 Professional Drive, Suite 200 Roseville, California 95661

Re: K091362

Trade/Device Name: Ceramic Pediatric Preformed Crown Regulation Number: 21 CFR 872.3330 Regulation Name: Preformed Crown Regulatory Class: I Product Code: ELZ Dated: May 8, 2009 Received: May 8, 2009

Dear Dr. Fisher:

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 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 - Dr. Fisher

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). . please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Keenan

Susan Runner, D.D.S., M.A. Acting 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:

Device Name: EZ-Pedo Inc. Ceramic Pediatric Preformed Crown

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz DDS for Dr. Kevin Mulry
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091362

Page 1 of

Regulation Number and Section

§ 872.3330 Preformed crown.

(a)
Identification. A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.