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

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.

AI/ML Overview

The provided documentation describes a 510(k) premarket notification for a dental device, SCULPTING RESIN. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic or treatment AI.

Therefore, many of the requested categories are not applicable or cannot be fully addressed from the given text. Below is an interpretation based on the information provided, highlighting what is present and what is missing.

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

For a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The performance is reported in terms of characteristics rather than quantitative outcomes against a predefined threshold.

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (SCULPTING RESIN)	Predicate Device Performance (ULTRADENT COMPOSITE WETTING RESIN)
Intended Use Equivalence: Device's intended use matches or is substantially similar to predicate.	Wetting resin.	Wetting resin.
Product Description Similarity: Key material properties and composition are comparable.	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 Similarity: Method of delivery to the point of use is comparable.	Bottle and syringe.	Syringe.
Biocompatibility: Device is non-toxic and safe for intended use.	Tested for biocompatibility and found to be non-toxic.	(Not explicitly stated for predicate in this summary, but presumed safe as legally marketed.)
Safety and Efficacy: The device is safe and effective for its intended use.	Concluded that the information supplied has proven the safety and efficacy.	(Presumed safe and effective as a legally marketed device.)

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

Not applicable. This is not a study involving a "test set" of patient data or clinical outcomes. The "testing" referred to is likely in-vitro physical/chemical property testing and biocompatibility testing of the material itself. The document does not specify the sample sizes for these tests, nor their provenance.

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. "Ground truth" in the context of expert consensus on patient data or images is not relevant for this type of device submission. The "ground truth" for material properties would be established through standard laboratory testing.

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

Not applicable. No expert adjudication method is mentioned or relevant to the information provided.

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 device is a dental material, not an AI or imaging device, so an MRMC study is completely irrelevant.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth used here pertains to material properties and biocompatibility. This would have been established through:

Chemical and physical characterization tests: To determine properties like viscosity, fill percentage, and curing characteristics.
Biocompatibility testing: Standardized in-vitro and/or in-vivo tests to assess for cytotoxicity, sensitization, irritation, etc., according to standards like ISO 10993.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable. No training set is involved.

Summary

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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:

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:

	BISCOSCULPTING RESIN	ULTRADENTCOMPOSITE WETTING RESIN
Intended Use	Wetting resin.	Wetting resin.
ProductDescription	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
DeliverySystem	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

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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.

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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

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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

Regulation Number and Section

§ 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.