(63 days)
Not Found
Not Found
No
The summary describes a resin material used for sculpting dental composites and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a composite sculpting resin intended to reduce tackiness when shaping composites, not to treat or prevent a disease or condition.
No
The device is described as a "pre-wetting agent for placing and sculpting layers of composites." Its function is to reduce tackiness when shaping composites, which is a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a "light-cured, low viscosity micro filled (30% by weight) resin formulation" supplied in a bottle and syringe, indicating it is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite." This is a material used during a dental procedure to facilitate the handling and shaping of composite materials.
- Device Description: The description reinforces its use as a "composite sculpting resin" applied to an instrument to reduce tackiness.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples to gain diagnostic information. This device is used in vivo (within the body, during a dental procedure) as a material to aid in the manipulation of other dental materials.
N/A
Intended Use / Indications for Use
The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
SCULPTING RESIN is a light-cured, low viscosity micro filled (30% by weight) resin formulation for use as a composite sculpting resin. It is supplied in a bottle and syringe. It is used on an instrument to reduce tackiness when shaping composites.
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)
SCULPTING RESIN was tested for biocompatibility and was found to be non-toxic.
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.
ULTRADENT COMPOSITE WETTING RESIN
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
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
APR 2 8 2003
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string begins with the letters "Ko", followed by the numbers "30585". The handwriting is somewhat stylized, with the numbers appearing slightly distorted.
Section 6-1
Image /page/0/Picture/3 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo is made up of six hexagons, each containing a letter of the company name. The text "Specialist In Adhesive and Composite Technology" is written below the logo.
Reisemy Science !
Bisco, Inc. 1100 W. Irving Park Road, Schaumburg, II.. 60193 U.S.A. Telephone: (847) 534-6000 or 1-800-BIS-DENT Fax: (847) 534-6396 WEB SITE http://www.bisco.com
Contact: Stephen D. Smith
SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92
Trade Name: Common Name: Classification name:
SCULPTING RESIN Wetting Resin Material, Tooth Shade, Resin Class II per 21 CFR 872.3690
Description of Applicant Device:
SCULPTING RESIN is a light-cured, low viscosity micro filled (30% by weight) resin formulation for use as a composite sculpting resin. It is supplied in a bottle and syringe. It is used on an instrument to reduce tackiness when shaping composites.
Intended uses of Applicant Device:
BISCO SCULPTING RESIN is for use as a composite wetting resin.
Predicate Devices: ULTRADENT COMPOSITE WETTING RESIN
Significant Performance Characteristics:
| | BISCO
SCULPTING RESIN | ULTRADENT
COMPOSITE WETTING RESIN |
|------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | Wetting resin. | Wetting resin. |
| Product
Description | Light-cured, low viscosity (30% filled), Methacrylates resin for use as a composite sculpting resin | Light cured, low viscosity (45% filled), Methacrylates resin used as a composite sculpting resin |
| Delivery
System | Bottle and syringe | Syringe |
Side by side comparisons of SCULPTING RESIN to the predicate device ULTRADENT COMPOSITE WETTING RESIN clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. SCULPTING RESIN was tested for biocompatibility and was found to be non-toxic.
It is concluded that the information supplied in this submission has proven the safety and efficacy of SCULPTING RESIN.
Stephen D. Smith Manager Regulatory Affairs Telephone: 847 534-6146 Fax: 847-534-6396
1
Image /page/1/Picture/1 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 three human profiles facing right, arranged in a stacked formation.
Public Health Service
APR 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Smith Manager of Regulatory Affairs Bisco, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193
Re: K030585
Trade/Device Name: Sculpting Resin Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: February 21, 2003 Received: February 24, 2003
Dear Mr. Smith:
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 Amendments, 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 controls provisions 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 your device can be found 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.
2
Page 2 - Mr. Steve Smith
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 regulation (21 CFR Part 801), 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) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at 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 vours.
Suza Quaro
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
of Sec. 2 Page 1
510(k) Number (if known):
036585
Device Name: Sculpting Resin
Indications For Use:
The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Kein Mulvey for MSA
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devi
510(k) Number: K030585