This material is intended for use in dentistry as a base or cavity liner under permanent restorations and for temporary restorations to teeth as an interim measure to protect cavities before a permanent restoration can be completed.

Device Description

These materials consist of a powder and liquid which, when mixed together, form a setting mass suitable for their intended use.

AI/ML Overview

The provided documentation is a 510(k) Premarket Notification for the "Super-Dent Intermediate Restorative Material," a temporary dental cement. The submission aims to demonstrate substantial equivalence to a predicate device (Temporary Dental Cement; 510(k) number K895487).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a formal table of acceptance criteria with numerical targets. Instead, the "NON-CLINICAL DATA" section discusses the characteristics of the device in comparison to the predicate device. The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device.

Characteristic	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Super-Dent Intermediate Restorative Material)
Setting Characteristics	Essentially identical to the predicate device at stipulated mixing ratios.	"The setting characteristics of these materials are essentially identical at the stipulated mixing ratios."
Compressive Strength	Comparable to the predicate device. (While not explicitly stated, a "slightly lower" performance would need to be justified and deemed acceptable for clinical use).	"The compressive strength of the subject device is slightly lower... than the predicate device."
Disintegration	Comparable to the predicate device. (Similar to compressive strength, a "slightly higher" performance would require justification for clinical acceptability).	"...and the disintegration slightly higher than the predicate device."
Mixing Ease	Not explicitly an "acceptance criterion" for performance, but presented as a beneficial characteristic that outweighs slight performance differences.	"The subject device is subjectively very much easier to mix which is an important advantage in surgery use." This ease of mixing is leveraged to justify the performance differences.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document refers to "the setting characteristics of these materials," "the compressive strength," and "the disintegration," implying that some tests were performed, but the number of samples or specimens used for these tests is not provided.
Data Provenance: The document (specifically "NON-CLINICAL DATA") describes lab-based testing comparing the subject device to the predicate device. The location of these tests is not specified, but the applicant (S.S. White Manufacturing, Ltd.) is based in England, so it's plausible the tests were conducted there. The nature of the data is retrospective in the sense that it's a comparison to an existing predicate device, and the testing was likely performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable as this is a materials science evaluation, not a diagnostic or interventional device requiring humanexpert interpretation for ground truth. The "ground truth" for material properties is established through standardized laboratory testing methods.

4. Adjudication Method for the Test Set:

Not applicable for a materials science evaluation. The results are from physical and chemical property tests, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No MRMC study was done. The device is a dental material, not an imaging or diagnostic device requiring human reader interpretation with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a dental material, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical data (setting characteristics, compressive strength, disintegration) is based on standardized laboratory testing methods for dental materials. These methods are designed to objectively measure physical and chemical properties. The comparison is made against the performance of a predicate device, which would have established its own performance characteristics through similar objective testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical dental material.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is used for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows a stylized, bold, and slanted text that reads "DWITE". The letters are thick and appear to be in a sans-serif font. The overall impression is one of a logo or a heading, possibly for a brand or organization named DWITE.

K972935 TAN 29, 1998 Page 18 OF 31

510 (k) 80

S.S. White Manufacturing IJAME :

Unit 9, Madleaze Estate, ADDRESS : Bristol Road, Gloucester, GL1 SSG England

01452 307171 PHONE No :

01452 307187 FAX No. :

Hugh Savell CONTACT : nugh Baver

DATE PREPARED: 4" August, 1997

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ప్రా

PREMARKET NOTIFICATION

510(k) SUMMARY (continued)

TRADE NAME:	Super-Dent Intermediate RestorativeMaterial
COMMON NAME:	Temporary Dental Cement
CLASSIFICATION NAME:	Cement, Dental
EQUIVALENT TO:	Temporary Dental Cement; 510(k) numberK895487

DESCRIPTION :

These materials consist of a powder and liquid which, when mixed together, form a setting mass suitable for their intended use.

INTENDED USE:

These materials are intended for use in dentistry as a base or cavity liner under permanent restorations and for temporary restorations to teeth.

TECHNOLOGICAL CHARACTERISTICS:

These materials rely on the reaction between zinc oxide and eugenol (4-Allyl-2-methoxyphenol) to form a setting mass. They are chemically modified to control the setting reaction and are reenforced with polymers to give enhanced strength and a surface more resistant to abrasion.

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SWTE

JAN 2 9 19

Page 20 OF 31

510 (k) SUMMARY (continued)

NON-CLINICAL DATA:

The setting characteristics of these materials are essentially identical at the stipulated mixing ratios. The compressive strength of the subject device is slightly lower and the disintegration slightly higher than the predicate device.

The subject device is subjectively very much easier to mix which is an important advantage in surgery use.

CLINICAL DATA:

There is none applicable.

CONCLUSIONS :

The data summarised above indicates that the subject device is substantially equivalent to the predicate device.

The slightly lower performance of the subject device is considered to be out-weighed by its easier mixing. This ensures a consistently homogenous mix and thereby more reliable performance in clinical use.

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Image /page/3/Picture/2 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around a stylized graphic. The graphic consists of three curved lines that resemble a bird in flight. The logo is black and white and appears to be of a government organization.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mr. Hugh Savell Technical and Compliance Manager S.S. White Manufacturing, Ltd. 9 Madleaze Estate, Bristol Road Gloucester, Gl1 5SG. England

Re : K972935 Super-Dent Intermediate Restorative Material Trade Name: Requlatory Class: II Product Code: EMA Dated: December 16, 1997 December 22, 1997 Received:

Dear Mr. Savell:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Savell

not affect any 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 requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim M. Wlatucki

Timothy A. Ulatowski Directpr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

ರಿ

Enclosure

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510(k) Number (if known):	K972935
Device Name:	SUPER-DENT INTERMEDIATE RESTORATIVE
Indications For Use:	MATERIAL

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Susan Runver
	(Division Sign-Off)
	Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K972935

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.