(48 days)
Not Found
No
The device description and intended use clearly define it as a dental filling material, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a dental filling material used to restore teeth, but it does not "treat" a disease.
No
The device is a composite filling material used for restorative dental procedures, not for diagnosing conditions.
No
The device description clearly states it is a "light-curing, radiopaque ceramic microhybrid composite filling material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that Arabesk® Top is a "light-curing, radiopaque ceramic microhybrid composite filling material" used for "anterior and posterior applications, as well as for inlay techniques." Its intended uses are all related to restoring and modifying teeth directly within the patient's mouth.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test on biological material.
Therefore, Arabesk® Top is a dental restorative material used for direct application in the mouth, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
-
- 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
-
- 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 |
| Anton-Flettner-Str. 1-3 |
| 27472 Cuxhaven |
| GERMANY |
| Tel: 011-49 47 21 719 0 |
| Fax: 011-49 47 21 719 140 |
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: (314) 721-0112 (314) 721-7591 Fax:
DATE THAT 510(k) SUMMARY WAS PREPARED
December 1, 1999
| 4. NAME OF THE MEDICAL DEVICE | |
|---|---|
| Classification name | Material, tooth shade, resin |
| (Dental 76 EBF) | |
| Common / usual name | Light-curing composite |
| filling material | |
| Proprietary names | ARABESK® TOP |
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
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 (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.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 |