DYRACT® EXTRA RESTORATIVE is a hybrid resin-DEVICE DESCRIPTION: DEVICE DESCREATIve material for use in filling all dental cavity classes. The direct Composite Testorative maingle paste that is filled into a cavity in increments up to 2 mm before visible light curing.

AI/ML Overview

The provided text is a 510(k) summary for the DENTSPLY International DYRACT® EXTRA RESTORATIVE dental material. This type of submission identifies a device's substantial equivalence to a predicate device and does not typically include detailed studies with acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies as would be found in a Premarket Approval (PMA) application or a more extensive clinical trial report.

Therefore, many of the requested details about acceptance criteria and study particulars are not available in the provided document. The 510(k) process focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel studies.

Here's a breakdown of the information that can be extracted or inferred, and what is not available:

1. A table of acceptance criteria and the reported device performance

Not Available. The 510(k) summary does not provide specific acceptance criteria or reported device performance in the manner of a clinical trial or engineering specification study. Instead, it states that the device's components are "present in marketed devices and found to be safe for dental use" and that "the prop and of the support the safety and effectiveness of DYRACT® EXTRA RESTORATIVE for the indicated uses." This suggests reliance on the predicate device's established performance and the known safety of the components.

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

Not Available. This information pertains to a specific study, which is not detailed in the 510(k) summary. Given the 510(k) nature, a test set in the context of device performance testing (beyond perhaps material property testing, which isn't detailed here) would likely not have been part of this submission.
Data Provenance: Not specified.

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)

Not Applicable / Not Available. Ground truth establishment by experts for a test set is relevant for diagnostic or AI-assisted devices where human interpretation is being compared or enhanced. This device is a dental restorative material. Its effectiveness and safety would typically be assessed through material science testing, biocompatibility studies, and potentially clinical observations over time, not through expert consensus on interpretations.

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

Not Applicable / Not Available. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or subjective assessments. This is not relevant for a dental restorative material's submission based on substantial equivalence.

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

Not Applicable. MRMC studies are used for diagnostic imaging devices, particularly those involving AI. This device is a dental restorative material, so an MRMC study is not relevant.

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

Not Applicable. This question relates to AI or automated diagnostic algorithms. This device is a dental restorative material, not an algorithm.

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

Not Applicable / Not Available. For a restorative material, "ground truth" might refer to material properties meeting specifications, clinical success rates (e.g., retention, absence of secondary caries, patient satisfaction), or biocompatibility assessments. The document does not specify these types of "ground truth" or how they were established or evaluated in a study. The primary "ground truth" for a 510(k) in this context is the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not Applicable / Not Available. This question relates to machine learning models. This device is a dental restorative material and does not involve a training set for an algorithm.

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

Not Applicable / Not Available. As above, this question relates to machine learning models, which are not relevant to this device.

In summary:

The provided 510(k) summary for DYRACT® EXTRA RESTORATIVE aims to demonstrate substantial equivalence to predicate devices (Dyract® AP Restorative, K973235 and Quixx® Posterior Restorative, K040144). It asserts that the components are common, safe, and effective. The submission does not include details of specific performance studies, test sets, or ground truth establishment that would be characteristic of a more rigorous clinical trial for a novel device or an AI-powered diagnostic tool.

Summary

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K050880

APR 2 2 2005

510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street. Suite 60 York, PA 17405-0872

CONTACT:	Helen Lewis
DATE PREPARED:	April 1, 2005
TRADE OR PROPRIETARY NAME:	DYRACT® EXTRA RESTORATIVE
CLASSIFICATION NAME:	Tooth shade resin material, 872.3690
PREDICATE DEVICES:	Dyract® AP Restorative, K973235Quixx® Posterior Restorative, K040144

INTENDED USE: DYRACT® EXTRA RESTORATIVE is indicated for Cavity Classes III, INTENDED OOE. D'ITCTCTC 21 21 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 11 intercuspal distance.

TECHNOLOGICAL CHARACTERISTICS: All of the components in DYRACT® EXTRA TECHNOLOGICAL CHARACTERREAD IN marketed devices and found to be safe for dental use. NESTORATIVE have been assum rogenents of DYRACT® EXTRA RESTORATIVE in the we believe that the prof and of the support the safety and effectiveness of DYRACT® EXTRA RESTORATIVE for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the seal.

APR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K050880

Trade/Device Name: Dyract® eXtra Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 04, 2005 Received: April 06, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaiter is substantially equivalent (for the indications for referenced above and nave decimilied the ace need in ess marketed in interstate commerce
use stated in the enclosure) to legally markets of marketed in interesthat use stated in the enclosure) to legally man technique in end mentiments, or to devices that proof to May 28, 1970, the chacinent date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMAA . You may have been reclassified in accordance with the provisions wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the ge Act (Act) that do not require approval or a prematiconsplay in the Act. The general therefore, market the device, subject to mai general sense par registration, listing of devices, good
controls provisions of the Act include requirements for annial register controls provisions of the Act morade requiritions against misbranding and adulteration.

ﭗ

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) interest major regulations affecting your device can be
may be subject to such additional controls. Existing major regulations FDA ma may be subject to such additions, Title 21, Parts 800 to 899. In addition, FDA may publish found in the Code of I caeral in the Federal Register.

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Page 2 – Ms. Helen Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that PDA S Issualice of a substition with other requirements of the Act or that FDA has made a delemination that your develop other Federal agencies. You must comply with any Federal statules and regulations administered of to: registration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: set forth in t all the Act's requirements, including, but nor incertains as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing procession in the product reading readin labeling (21 CFR Part 801), good manabitant (2) Production (2001), and if applicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if appli systems (QS) regulation (21-531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceing your arrial equivalence of your device to a legally premarket nothcation. The PDA Intentify of baosanian organ
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 If you desire specific advice for your do note the regulation of the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the office of contact the Office of Compulance at (210) 270 of 10.17 PM Part 807.97). You may obtain other
"Misbranding by reference to premarket notification' (21 CFR Part Division of Sw "Misbranding by relefence to premail.cricans.com the Act from the Division of Small
general information on your responsibilities under the Act from the Universe (800) 6 general international on your responsionnes assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collsaner Floram. For and Consistencial of Collection of Chindex.html.

Sincerely yours,

Suite y. Mahieu MD.

Chiu S. Lin, PhD 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 STATEMENT

ﻢ

510(K) Number (if known):

K050880

Device Name:

DYRACT® EXTRA RESTORATIVE

Indications for Use:

Premarket Notification

Indicated for

Cavity Classes III, IV, V, and VI .
Cavity Classes I and II where the cavity preparation is less than ½ of the intercuspal ● distance

Prescription Use __X (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)

Supa Ramsey

wision Sign-Off) vision of Anesthesiology, General Hospital, mection Control, Dental Devices

Number: 1903082

DYRACT® EXTRA RESTORATIVE

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.