Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during teeth whitening procedures. The material is dispensed from a syringe into the gingival crest just shy of the tooth structure. The resin is light-cured (polymerized) on the soft tissue by exposure for 20 seconds per section of material.

AI/ML Overview

This submission is for a Class II medical device, Niveous Liquid Dam, intended to protect soft tissue during in-office bleaching. It is a 510(k) premarket notification, which means the device's acceptance criteria are centered on demonstrating substantial equivalence to a predicate device, rather than proving novel performance metrics through a clinical study with acceptance criteria.

Therefore, the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and MRMC studies, as typically found in clinical trials for novel devices with performance claims, is not applicable in this 510(k) summary. The "study" for this device is the comparison of its characteristics to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, formal quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance metrics (e.g., exact measured diagnostic accuracy) in a clinical study are not provided in this document. The "acceptance criteria" are based on demonstrating comparable characteristics and intended use to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicate devices for its intended use.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison to predicate)
Intended Use: Protect soft tissue during in-office bleaching	Identical Intended Use: "The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching." (Page 1 and 5)
Technological Characteristics: Similar chemical composition and physical/chemical characteristics to predicate devices.	"The chemical composition is comparable to FastDam, 510(k) K972775, and has the same physical and chemical characteristics." This implies the device meets the performance characteristics of the predicate, though specific numerical values are not reported. (Page 2)
Biocompatibility: Safe for soft tissue contact.	"Niveous Liquid Dam is similar in use and formulation to other dental dams that have been on the market for several years... The formulation does not contain any new or non-conventional chemicals; therefore, new biocompatibility testing is unwarranted." This indicates comparable biocompatibility to established devices. (Page 2)
Safety and Effectiveness: No new questions of safety or effectiveness raised.	The FDA's clearance (K021613) implies that no new questions of safety or effectiveness were raised relative to the predicate devices. (Page 3)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No "test set" in the sense of a clinical trial dataset with patient samples was used for this 510(k) submission as it focuses on substantial equivalence based on material properties and intended use.
Data Provenance: Not applicable for a traditional clinical "test set." The data provenance for the comparison is the existing regulatory files and market history of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No external experts were used to establish ground truth for a clinical test set as part of this submission. The "ground truth" for substantial equivalence is based on the known characteristics and approved status of the predicate devices.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No formal adjudication method for a clinical test set was employed as part of this 510(k) submission.

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

MRMC Study: No. This device is a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
Effect Size: Not applicable.

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

Standalone Performance Study: No. This device is a physical dental material, not an algorithm.

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

Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness profile, chemical composition, physical characteristics, and intended use of the legally marketed predicate devices (FastDam [K972775] and OpalDam [K971284]). The applicant demonstrated that Niveous Liquid Dam is sufficiently similar to these predicates.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a dental material, not an AI/machine learning algorithm, so there is no "training set" in that context. The development of the material would involve internal R&D and quality control, but not a "training set" as understood in AI studies.

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

Ground Truth for Training Set Establishment: Not applicable. As there is no AI training set, this question is not relevant.

Summary

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JUN 2 0 2002

Image /page/0/Picture/1 description: The image shows a black circle with the word "SHOFU" in white, block letters across the center. The "R" in a circle, indicating a registered trademark, is located in the bottom right corner of the circle. The logo is simple and uses a contrasting color scheme to make the text stand out against the dark background.

DENTAL CORPORATION 5 Stone Drive, San Marcos, California 92069-4059 U.S.A. el.: (760) 736-3277 • FAX.: (760) 736-3276

KQ21613

510(k) SUMMARY

Submitted by:	Robert Noble, PresidentShofu Dental Corporation1225 Stone DriveSan Marcos, CA 92069-4059(760) 736-3277FAX: (760) 736-3276
Company Contact:	Robert Noble, President
Date Summary Prepared	May 14, 2002
Trade Name	Niveous Liquid Dam
Common Name	Resin dam
Classification	EIE
Product Code	872.6300
Substantially Equivalent Devices	FastDam [510(k) Number - K972775]OpalDam [510(k) Number - K971284]

Description of Niveous Liquid Dam

Intended Use:

The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

Shofu Dental Corporation Niveous Liquid Dam 510(k) Summary

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Image /page/1/Picture/0 description: The image shows a black circle with the word "SHOFU" in white letters inside. The letters are bold and sans-serif. There is a horizontal line that runs through the middle of the word. The registered trademark symbol is located in the bottom right corner of the circle.

DENTAL CORPORATION ne Drive, San Marcos, California 92069-4059 U.S.A. ) 736-3277 • FAX .: (760) 736-3276

Kit Components:

Niveous Liquid Dam is a component in the Niveous Professional Tooth Whitening System. The kit consists of the following components:

1. Syringe containing Niveous Liquid Dam
1. Bleach Gel Droplet
1. Booster Brush
1. Dappen Dish

Biocompatibility

Niveous Liquid Dam is similar in use and formulation to other dental dams that have been on the market for several years. (Interdent Incorporated, FastDam 510(k) K972775, among others) The formulation does not contain any new or non-conventional chemicals; therefore, new biocompatibility testing is unwarranted.

Nonclinical tests that support a determination of substantial equivalence

The chemical composition is comparable to FastDam, 510(k) K972775, and has the same physical and chemical characteristics.

Conclusion

The Niveous Liquid Dam is substantially equivalent to other liquid dam resins such as FastDam 510(k) K972775 and OpalDam 510(k) K971284.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2002

Mr. Robert Noble President Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059

Re: K021613

Trade/Device Name: Niveous Liquid Dam Regulation Number: 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: May 14, 2002 Received: May 16, 2002

Dear Mr. Noble:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act, However, you are responsible for determining that the medical devices you use as components of the Niveous kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the Act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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

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Page 2 - Mr. Robert Noble

requirements as set forth in the quality systems (QS) 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 the labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). 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 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

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INDICATIONS FOR USE

K021613.

510(k) Number (if known):

Device Name:

Niveous Liquid Dam

Indications For Use:

The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rump

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F : O(k) Number_ KOS-11-

(Optional Format (3-10-98)

Shofu Dental Corporation Niveous Liquid Dam 510(k) Premarket Notification

Regulation Number and Section

§ 872.6300 Rubber dam and accessories.

(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.