ARABESK FLOW

K994304 · Voco GmbH · EBF · Feb 7, 2000 · Dental

Device Facts

• Record ID: K994304
• Device Name: ARABESK FLOW
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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)

Device Story

Arabesk Flow is a light-curing, radiopaque glass ceramic microhybrid composite dental filling material. Composition includes 69% inorganic fillers (silica, barium/strontium borosilicate glass, 0.7um average size) and 30% dimethacrylates (BIS-GMA, urethane dimethacrylate, triethyleneglycol dimethacrylate). Supplied in bulk syringes or single-use applicator-tip capsules. Used by dentists in clinical settings for restorative procedures. Material applied to tooth cavity; low viscosity ensures wetting and adhesion; polymerized using halogen light. Provides high-strength, color-stable, polishable restorations. Benefits include improved cavity adaptation, reduced air entrapment, and efficient filling process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing of performance properties including viscosity, compressive strength, polymerization shrinkage, color stability, and resistance to abrasion compared to predicate devices.

Technological Characteristics

Light-curing, radiopaque glass ceramic microhybrid composite. Composition: 69% inorganic fillers (silica, barium/strontium borosilicate glass), 30% dimethacrylates (BIS-GMA, urethane dimethacrylate, triethyleneglycol dimethacrylate). Polymerization via halogen light. Form factor: bulk syringes or single-use applicator-tip capsules.

Indications for Use

Indicated for dental restorations in anterior and posterior teeth, including minimally invasive preparations, small cavities, extended fissure sealing, cavity undercuts, Class III-V fillings, cervical caries, repair of fillings/veneers, and luting of translucent prosthetic pieces.

Regulatory Classification

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.

Predicate Devices

• Tetric Flow (K964285)
• Flow Line (K990756)

Submission Summary (Full Text)

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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: [phone] - 0 intl.: [phone]

Telefax: (0 47 21) 7 19 - 1 09 intl.: [phone]

Internet: http://www.voco.de e-mail: [e-mail]

Ihr Zeichen yr. ref.

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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
- 2. CONTACT PERSON for VOCO GmbH
- 3. DATE THAT 510(k) SUMMARY WAS PREPARED
- 4. NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary)
- 5. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
- 6. DESCRIPTION OF THE DEVICE
- 7. INTENDED USE OF THE DEVICE
- 8. 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: [phone]

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القرآن
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U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH

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

Tel: [phone] [phone] Fax:

DATE THAT 510/k) SUMMARY WAS PREPARED

December 21, 1999

| <b>4. NAME OF THE MEDICAL DEVICE</b> | |
|--------------------------------------|------------------------------------------------------|
| Classification name | Material, tooth shade, resin<br>(Dental 76 EBF) |
| Common / usual name | Flowable, light-curing composite<br>filling 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 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).

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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) | <div> <span></span> </div> |
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| Over-The-Counter Use | <div> <span></span> </div> |
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| (Division Sign-Off) | <div> <span></span> </div> |
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| Division of Dental, Infection Control, and General Hospital Devices | <div> <span></span> </div> |
| 510(k) Number | <div> <span></span> </div> |