Rebilda SC is a self-curing, highly radiopaque, flowable composite for core buildup. Rebilda SC has excellent mechanical properties. Rebilda SC is available in two shades, light blue and dentine. The light blue shade shows the preparation two onado, light blue tin shade is for use under translucent crowns and bridges. margins, while the achieved by using Rebilda SC in conjunction with the light-curing dentin/enamal bonding agent Solobond Plus.

AI/ML Overview

The provided document is a 510(k) summary for a dental core build-up material called Rebilda SC. It focuses on establishing substantial equivalence to a predicate device based on material properties rather than clinical performance or AI algorithm evaluation. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), ground truth establishment, expert qualifications, and sample sizes for AI model training/testing are not present in this document.

However, I can extract the information that is available:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. Instead, it states that the device is "substantially equivalent with regard to such physical properties as compressive strength, flexural strength, working time, and hardness" to the predicate device, Luxacore (K982201). This implies that the performance of Rebilda SC in these physical properties met or was comparable to that of the predicate device, which would be the implicit acceptance criteria for these material characteristics.

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

This information is not provided in the document. The studies mentioned are "Preclinical Performance Studies," which typically refer to bench testing of material properties, not clinical trials with human subjects or AI model evaluation.

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)

This information is not applicable and therefore not provided, as this is not an AI or diagnostic imaging device requiring expert ground truth for a test set.

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

This information is not applicable and therefore not provided.

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

No MRMC study was conducted or mentioned, as this is a dental material, not an AI-powered diagnostic device.

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

No standalone algorithm performance study was conducted or mentioned, as this is a dental material, not an AI-powered diagnostic device.

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

The "ground truth" equivalent for this type of device would be established through standardized material testing methods (e.g., for compressive strength, flexural strength, working time, and hardness) as defined by relevant ISO or EN standards (e.g., EN 24049/ISO 4049). The document states "Rebilda SC corresponds to EN 24049/ISO 4049," indicating compliance with these material standards.

8. The sample size for the training set

This information is not applicable and therefore not provided, as this is not an AI-powered device developed using machine learning.

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

This information is not applicable and therefore not provided.

Summary of what is available from the document:

Acceptance Criteria & Performance: "Substantial equivalence" to Luxacore (K982201) regarding physical properties like compressive strength, flexural strength, working time, and hardness. Compliance with EN 24049/ISO 4049.
Study Type: Preclinical performance studies (bench testing of material properties).
Ground Truth (for material properties): Established by standardized material testing methods according to EN 24049/ISO 4049.

Summary

{0}------------------------------------------------

Image /page/0/Figure/27 description: The image shows four black shapes arranged horizontally. The first shape is a triangle with a small rectangle cut out of the top. The second shape is a circle with a smaller circle cut out of the center. The third shape is a circle with a cone-shaped section removed. The fourth shape is a circle with a smaller circle cut out of the center.

K014111

(TVOCO GmbH · P.O.B./ Postfach 767 · D-27457 Cuxhaven (Germany)

6 2002 MAR

Anton-Flettner-Straße 1-3 D-27472 Cuxhaven (Germany)

Telefon: (0 47 21) 7 19 - 0 intl.: +49 (47 21) 7 19-0

Telefax: (0 47 21) 7 19 - 1 09 intl.: +49 (47 21) 7 19 - 1 40

Internet: http://www.voco.de e-mail: info@voco.de

Inr Zeichen yr. ref.

ﺎ.

Ihre Nachricht vom did.

Unser Zeichen our ref.

ﻟـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Datum date

510(k) SUMMARY

REBILDA® SC (76 EBF)

Submitter's Name 1.
Contact Person For VOCO GmbH 2.
Date that 510(k) Summary Was Prepared 3.
Date that 5 ro(k) Sunnaly viao Free (Classification / Common / Proprietary)
Name of the Medical Device (Classification / Common / Proprietany)
1. Name of the Medical Device (Olasonoution) Solassinoution is Claimed 5.
Description of the Device હ.
Intended Use of the Device 7.
Thended Use of the Dovice 8.
Technological Companson Domoon Starformance Studies and Conclusions From 9.
Preclinical Performance Studies

1. SUBMITTER'S NAME
VOCO GmbHAnton-Flettner-Str. 1-327472 CuxhavenGERMANY
Tel: 011-49-47 21 719 0Fax: 011-49 47 21 719 140

{1}------------------------------------------------

U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH 2.

Evan Dick, Ph.D E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, MO 63105

(314) 721-0112 Tel: Fax: (314) 721-7591

DATE THAT510(k) SUMMARY WAS PREPARED 3.

December 13, 2001

4. NAME OF THE MEDICAL DEVICE
Classification name	Material, tooth shade, resin(Dental 76 EBF)
Common / usual name	Self-curing dental restorative material
Proprietary name	Rebilda SC

5. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

Luxacore (K982201, Foremost Dental Mfg.)

{2}------------------------------------------------

DESCRIPTION OF THE DEVICE ਵ

Rebilda SC corresponds to EN 24049/ISO 4049

INTENDED USE OF THE DEVICE

Rebilda SC is intended to be used for core build-up of vital and non-vital teeth.

ECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES

Rebilda SC and Luxacore (K982201) are both two-component, self-curing, flowable composites. Both products are primarily composed of silicate glass, methacrylate polymers, and curing catalysts. Both products are substantially equivalent with regard to such physical properties as compressive strength, flexural strength, working time, and hardness.

SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND 9. CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES

Rebilda SC is formulated from chemical components that are commonly associated with currently marketed dental composite materials.

The chemistry of Rebilda SC raises no new issues or questions that effect safety, effectiveness, or biocompatibility for dental composite product.

{3}------------------------------------------------

Image /page/3/Picture/2 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 symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002 MAR

Voco GmbH C/O Dr. Evan Dick E. G. Dick & Associates 7527 Westmoreland Avenue Saint Louis, Missouri 63105

Re: K014111

Trade/Device Name: Rebilda SC Regulation Number: 872.3690 Regulation Name: Tooth Shade, Resin Material Regulatory Class: II Product Code: EBF Dated: December 14, 2001 Received: December 14, 2001

Dear Dr. Dick:

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 mendments, 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 approvisions 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 (1 11 1), 1 million 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.

{4}------------------------------------------------

Page 2 - Dr. Dick

You must comply with all the Act's requirements, including, but not limited to: registration 1 od intiles compry wart 807); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 CF Part 2017), 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 11 mis letter will and in Jourie Cognit 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 If you desire up of CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance 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 ulle Act may be obtained 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K014/////'

Rebilda SC Device Name:

Indications For Use:

Rebilda SC is a self-curing, radiopaque, flowable composite intended to be used for core build-up in vital and non-vital teeth.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

(as per 21 CFR 801.109)

unne ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign-Off) Division of Dental, Infection Control, - General Hospital Devices · · Number_Kolall Status and States of Concession Comments of

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.