ARABESK TOP

K994268 · Voco GmbH · EBF · Feb 3, 2000 · Dental

Device Facts

• Record ID: K994268
• Device Name: ARABESK TOP
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Arabesk Top is a composite filling material for both anterior and posterior applications, as well as for inlay techniques. Indications for use are: - Class I-V fillings - Reconstruction of traumatically affected anteriors - Veneering of discolored anteriors - Color and/or shape corrections to improve asthetic appearance - Locking or splinting of loose anteriors - Extended fissure sealaing for molars and premolars - Repairing veneers - Core build-up under crowns - Especially suitable for composite inlays

Device Story

Arabesk Top is a light-curing, radiopaque ceramic microhybrid composite filling material used by dentists in clinical settings for restorative dental procedures. The material consists of inorganic fillers (77% by weight), including microfillers and small particle fillers, suspended in a methacrylate monomer matrix (BIS-GMA, UDMA, TEDMA). It is supplied in bulk syringes or single-use applicator-tip capsules. The clinician applies the composite to the prepared tooth site and cures it using a dental light-curing unit. The material hardens to provide structural restoration, aesthetic correction, or stabilization of teeth. It serves as a direct replacement for damaged or decayed tooth structure, benefiting patients by restoring function and appearance.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence is based on chemical composition and physical performance property comparisons to legally marketed predicate devices.

Technological Characteristics

Light-curing, radiopaque ceramic microhybrid composite. Composition: 77% w/w inorganic fillers (microfillers ~0.05um, small particle fillers ~0.7um), ~20-22% w/w methacrylate monomers (BIS-GMA, UDMA, TEDMA), photoinitiators, and pigments. Form factor: bulk dispensing syringes or single-use applicator-tip capsules.

Indications for Use

Indicated for patients requiring dental restorations including Class I-V fillings, reconstruction of traumatically affected anteriors, veneering of discolored anteriors, color/shape corrections, locking/splinting of loose anteriors, extended fissure sealing for molars/premolars, veneer repair, and core build-up under crowns.

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 Ceram (K964285)
• Charisma (K910263, K954929)

Submission Summary (Full Text)

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

Image /page/0/Figure/0 description: This image shows a letterhead from VOCO GmbH, dated February 3, 2000. The letterhead includes the company's address as Postfach 767, 27457 Cuxhaven, and the physical address as Anton-Flettner-Straße 1-3, 27472 Cuxhaven, Germany. Contact information includes the telephone number (0 47 21) 719-0, telefax number (0 47 21) 719-109, and telex number 2 32 202 dent d.

# 510(k) SUMMARY

# ARABESK® TOP (76 EBF)

- 1. SUBMITTER'S NAME
- CONTACT PERSON for VOCO GmbH 2.
- DATE THAT 510(k) SUMMARY WAS PREPARED 3.
- NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary) 4.
- LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED ട്.
- e. DESCRIPTION OF THE DEVICE
- 7. INTENDED USE OF THE DEVICE
- TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES 8.
- SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM 9. PRECLINICAL PERFORMANCE STUDIES

| 1. SUBMITTER'S NAME |
|-------------------------------------------------------------------|
| VOCO GmbH<br>Anton-Flettner-Str. 1-3<br>27472 Cuxhaven<br>GERMANY |
| Tel: [phone]<br>Fax: [phone] |

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

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 1, 1999

| 4. NAME OF THE MEDICAL DEVICE | |
|-------------------------------|-------------------------------------------------|
| Classification name | Material, tooth shade, resin<br>(Dental 76 EBF) |
| Common / usual name | Light-curing composite<br>filling material |
| Proprietary names | ARABESK® TOP |

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

- Tetric Ceram (K964285, Ivoclar)
- · Charisma (K910263, K954929, Kulzer)

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

# DESCRIPTION OF THE DEVICE

Arabesk Top is a light-curing, radiopaque ceramic microhybrid composite filling material for both anterior and posterior applications, as well as for inlay techniques. Arabesk Top contains 77% by weight (56% by volume) inorganic fillers, microfillers (~ 0.05um), and small particle fillers (~0.71m). The methacrylate monomers consist of BIS-GMA, UDMA, and TEDMA.

Arabesk Top is available in bulk dispensing syringes (4gm each) and in singleuse applicator-tip capsules (0.25 gm each).

INTENDED USE OF THE DEVICE

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

- · Class I-V fillings
- Reconstruction of traumatically affected anteriors
- · Veneering of discolored anteriors
- · Color and/or shape corrections to improve asthetic appearance
- · Locking or splinting of loose anteriors
- · Extended fissure sealaing for molars and premolars
- · Repairing veneers
- · Core build-up under crowns
- · Especially suitable for composite inlays

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

### TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES

Arabesk Top, Tetric Ceram, and Charisma are all single-component, lightcuring composite filling materials that are composed of inorganic silicates ( 72-77%, w/w), methacrylates (~20-22%, w/w), photoinitiators and pigments (~1%. w/w). The subject and predicate devices are substantially alike with respect to such performance properties as compressive strength, polymerization shrinkage, color stability, and resistance to abrasion.

SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES

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

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

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2000 FEB

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

K994268 Re : Material, tooth shade, resin (Dental 76 EBF) Trade Name: Regulatory Class: II Product Code: EBF December 17, 1999 Dated: Received: December 17, 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, Drug, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 requlation 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

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

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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{6}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K994268_

Arabesk® Top Device Name:

Indications For Use:

Arabesk® Top is a light-curing, radiopaque ceramic microhybrid composite filling material for both anterior and posterior applications, as well as for inlay techniques. Arabesk® Top is intended for use in restoring:

- · Class I-V fillings
- Reconstruction of traumatically affected anteriors
- Facetting of discolored anteriors
- · Color and/or shape corrections to improve asthetic appearance
- · Locking or splinting of loose anteriors
- · Extended fissure sealaing for molars and premolars
- · Repairing veneers
- Core build-up under crowns
- · Especially suited for composite inlays

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | | OR | Over-The-Counter Use |
|----------------------|--|----|----------------------|
| (per 21 CFR 801.109) | | | |

| (Division Sign-Off) | Susan Runna |
|---------------------------------------------------------------------|-------------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | 1994268 |