fillings requiring minimally invasive preparation
fillings for small cavities
extended fissure sealing
substitute fillings of cavities with undercuts
Class III-V fillings including V-shaped defects and cervical caries
repair of fillings and veneers
luting of translucent prosthetic pieces (e.g., procelain-only crowns)

Device Description

Arabesk Flow is a light-curing and radiopaque glass ceramic microhybrid composite. It is suited for fillings in both anterior and posterior applications. Arabesk Flow's low viscosity results in excellent wetting and adhesion to the tooth. Arabesk Flow produces a high strength and color stable restoration that can be polished to a high gloss. Arabesk Flow is polymerized (cured) by halogen light. Arabesk Flow conforms well to cavity surfaces, helps to avoid trapped air, and speeds cavity filling.
Arabesk Flow contains 69% inorganic fillers (highly pure silica and barium/strontium borosilicate glass particles - average size 0.7um) and 30% dimethacrylates (BIS-GMA, urethane dimethacrylate, triethyleneglycol dimethacryrlate).
Arabesk Flow is available in bulk dispensing syringes (3gm each) and in single-use applicator-tip capsules (0.25 gm each).

AI/ML Overview

This document is a 510(k) Summary for a dental composite filling material, ARABESK® FLOW. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria in the way one might expect for a diagnostic or AI-driven device.

Therefore, much of the requested information regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment cannot be directly extracted from the provided text. The document does not describe a clinical study of ARABESK® FLOW against specific performance metrics with acceptance criteria, but rather a preclinical comparison to predicate devices.

Here's what can be extracted and what cannot:

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

The document does not explicitly state acceptance criteria or provide a table of performance data against those criteria. Instead, it makes a general statement about technological comparison.

Acceptance Criteria (Implied)	Reported Device Performance
Viscosity similar to predicates	"substantially alike with respect to such performance properties as viscosity"
Compressive strength similar to predicates	"substantially alike with respect to such performance properties as... compressive strength"
Polymerization shrinkage similar to predicates	"substantially alike with respect to such performance properties as... polymerization shrinkage"
Color stability similar to predicates	"substantially alike with respect to such performance properties as... color stability"
Resistance to abrasion similar to predicates	"substantially alike with respect to such performance properties as... resistance to abrasion"
Chemical composition similar to predicates	"composed of inorganic silicates (~60-70%, w/w/), dimethacrylates (~30-40%, w/w/), photoinitiators and pigments (~1%. w/w)"

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

Sample size: Not specified. The document refers to "preclinical performance studies" but does not detail the methodology, sample sizes, or data provenance.
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. This is a material science characterization, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. No expert adjudication is mentioned or implied for the preclinical performance studies.

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. This is a dental filling material, not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This is a dental filling material, not an algorithm or AI device.

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

The "ground truth" for the preclinical performance studies would be the actual measured physical and chemical properties of the material, using standardized laboratory methods, and then compared against similar measurements of the predicate devices. This isn't "ground truth" in the clinical sense (like pathology for cancer diagnosis), but rather established material properties.

8. The sample size for the training set

Not applicable. This is a material, not a machine learning model requiring a training set.

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

Not applicable. This is a material, not a machine learning model requiring a training set.

Summary of Preclinical Performance Studies and Conclusions (from the document):

The document states:
"SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES"
However, the actual details of these studies are not provided in the excerpt. It only concludes that the chemistry of Arabesk Flow "raises no new issues or questions that effect safety, effectiveness, or biocompatibility for a dental composite product" and that the product is "substantially alike" to predicate devices in performance properties.

Summary

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7 2000 FEB

Image /page/0/Picture/1 description: The image shows a logo with the word "VOCO" in large, stylized letters above the number "K994304". The letters of "VOCO" are designed with geometric shapes, with the "V" resembling an inverted triangle, the "O" as a solid circle, the "C" as a partial circle, and the second "O" as another solid circle. The number "K994304" is written in a handwritten style, and there is a horizontal line below the number.

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

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

Ihr Zeichen yr. ref.

ﻟﺴﻴ

Ihre Nachricht vom dtd.

Unser Zeicher our ref.

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Datum date

510(k) SUMMARY

ARABESK® FLOW (76 EBF)

1. SUBMITTER'S NAME
1. CONTACT PERSON for VOCO GmbH
1. DATE THAT 510(k) SUMMARY WAS PREPARED
1. NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary)
1. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
1. DESCRIPTION OF THE DEVICE
1. INTENDED USE OF THE DEVICE
1. TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES
SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM 9. PRECLINICAL PERFORMANCE STUDIES

SUBMITTER'S NAME VOCO GmbH Anton-Flettner-Str. 1-3 27472 Cuxhaven GERMANY 011-49 47 21 719 0 Tel: Fax: 011-49 47 21 719 140

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القرآن
な ﻬ

page 2 of 4

U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH

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

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

DATE THAT 510/k) SUMMARY WAS PREPARED

December 21, 1999

4. NAME OF THE MEDICAL DEVICE
Classification name	Material, tooth shade, resin(Dental 76 EBF)
Common / usual name	Flowable, light-curing compositefilling material
Proprietary names	ARABESK® FLOW

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

Tetric Flow (K964285, Ivoclar)
· Flow Line (K990756, Kulzer)

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DESCRIPTION OF THE DEVICE

Arabesk Flow contains 69% inorganic fillers (highly pure silica and barium/strontium borosilicate glass particles - average size 0.7um) and 30% dimethacrylates (BIS-GMA, urethane dimethacrylate, triethyleneglycol dimethacryrlate).

Arabesk Flow is available in bulk dispensing syringes (3gm each) and in single-use applicator-tip capsules (0.25 gm each).

INTENDED USE OF THE DEVICE

Arabesk Flow is a composite filling material for both anterior and posterior applications, as well as for inlay techniques. Indications for use are:

· Fillings requiring minimally invasive preparation
· Fillings for small cavities
· Extended fissure sealing
· Substitute fillings of cavities with undercuts
· Class III-V fillings including V-shaped defects and cervical caries
· Repair of fillings and veneers
Luting of translucent prosthetic pieces (e.g., procelain-only crowns)

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TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES

Arabesk Flow, Tetric Flow (K964285), and Flow Line (K990756) are all flowable, light-curing, glass ceramic composite filling materials for use in both anterior and posterior sites.

Arabesk Flow, Tetric Flow, and Flow Line are all composed of inorganic silicates (~60-70%, w/w/), dimethacrylates (~30-40%, w/w/), photoinitiators and pigments (~1%. w/w). The subject and predicate devices are substantially alike with respect to such performance properties as viscosity, compressive strength, polymerization shrinkage, color stability, and resistance to abrasion.

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

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

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an emblem featuring three stylized human figures or profiles, possibly representing health, family, and community.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Evan G. Dick, Ph.D. E.G. Dick & Associates c/o 7527 Westmorland Avenue St. Louis, Missouri 63105

Re: K994304 Material, tooth shade, resin (Dental 76 EBF) Trade Name: Requlatory Class: II Product Code: EBF December 21, 1999 Dated: Received: December 21, 1999

Dear Mr. Dick:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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

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Page 2 - Mr. Dick

obligation you might have under sections 531 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 begin 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 requlation (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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K994304

Arabesk® Flow Device Name:

Indications For Use:

Arabesk Flow® is a flowable, light-curing and radiopaque glass ceramic microhybrid composite. It is suitable for restorations in both anterior and posterior applications. Arabesk® Flow is intended for:

· fillings requiring minimally invasive preparation
· fillings for small cavities
· extended fissure sealing
· substitute fillings of cavities with undercuts
Class III-V fillings including V-shaped defects and cervical caries
· repair of fillings and veneers
· luting of translucent prosthetic pieces (e.g., procelain-only crowns)

(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
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(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number

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.