This device is used as a sealing material for pit and fissure. This intended use is same to that of similar products which are identified in the paragraph 4.

Device Description

This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.

AI/ML Overview

This document describes the safety evaluation of TEETHMATE F-1, a pit and fissure sealant. It focuses on the biocompatibility of a new ingredient, TMDPO, as well as the leachables from the cured resin. The study is a series of in vitro and in vivo toxicology tests.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Acute Toxicity of TMDPO (LD50)	Not explicitly stated, but typically a high LD50 indicating low toxicity.	LD50 > 4,000 mg/kg (indicating low acute toxicity)
Subacute Toxicity of TMDPO	Negative (no adverse effects observed)	Negative (no adverse effects observed at 13mg/kg/day over 25 days)
Genotoxicity (Ames Test) of TMDPO	Negative (no mutagenic activity)	Negative across all tested bacterial species for both direct and metabolic activity tests
Amount of TMDPO Leached from Cured Resin	Not explicitly stated, but implicitly a very low or undetectable amount for safety.	Less than identification limit (0.04 ppm) for both 37°C and 50°C conditions
Acute Toxicity of Leachables (effect on mouse weight and mortality)	No significant effect on mouse weight and no mortality.	No effect on mouse weight and no mouse died.

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

Acute Toxicity of TMDPO: Mice were used. Specific number not provided, but typically a small group for LD50 determination.
Subacute Toxicity Test: Rats were used. Specific number not provided, but typically a group for control and various doses.
Genotoxicity Test (Ames Test): Bacterial species (Escherichia coli WP2 uvrA and Salmonella typhimurium TA100, TA1535, TA98, TA1537) were used. These are in vitro tests, not animal or human subjects.
Amount of TMDPO Leached from Cured Resin: Two pieces of cured resin (10mm Φ × 5mm) were tested separately for each condition (37°C and 50°C). This is an in vitro test.
Acute Toxicity of Leachables: ICR mice were used. The number of mice is not explicitly stated, but implied to be sufficient for a toxicity study. Approximately 44 cylindrical specimens of cured resin (3mm Φ × 3mm) were used per gram of specimen for extraction. This is an in vivo test.

Data Provenance: All studies were conducted by Kuraray Co., Ltd. or The Kitasato Institute, both located in Japan. The studies appear to be prospective toxicology and biocompatibility evaluations specifically designed for this device.

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

This document describes toxicology and biocompatibility studies, not clinical efficacy or diagnostic accuracy studies that would typically involve a "ground truth" established by experts in that context. The "truth" in these studies is derived from laboratory measurements (e.g., LD50, ppm leached) and observed biological responses (e.g., animal health, genetic mutations). The expertise lies in toxicology and laboratory science, and the institutions conducting the tests (Kuraray Co., Ltd. and The Kitasato Institute) are expected to have qualified scientists and technicians to perform these studies according to standard protocols.

4. Adjudication Method for the Test Set

Not applicable. This is a toxicology and material leaching study, not a study involving human interpretation of data requiring adjudication.

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 is not a diagnostic device or an AI-assisted device. It is a dental material (pit and fissure sealant).

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" in these studies is based on:

Toxicological endpoints: Survival, organ/tissue changes, genetic mutations as per established toxicology protocols.
Chemical analysis: Quantification of leached substances using analytical techniques like high-pressure liquid chromatography (HPLC).
Biocompatibility standards: Assessment against known biological responses to materials.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this device.

Summary

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[TEETHMATE F-1, Kuraray]

12-39, Umeda, Kita-ku, Osaka 530, Jap

MAR 2 7 1997

510(K) SUMMARY

1. Submitter

: Kuraray Co.,Ltd. 1) Name : 1-12-39, Umeda, Kita-ku, Osaka 530, Japan 2) Address : 81(Japan) 6-348-2603 3) Telephone : 81(Japan) 6-348-2552 or 2805 4) Facsimile : Yoshinori Nagase 5) Contact person Dental Material Department Medical Product Division 6) Date : December 3,1996

Representing (Subsidiary of Kuraray Co.,Ltd.)

: Kuraray America Inc. 1) Name : 30th FI. Metlife Building, 200 Park Avenue, New York, NY 10166 2) Address 3) Telephone : (212) 986-2230 : (212) 867-3543
1. Facsimile
: Koji Fujita 5) Contact person
- President

3. Name of device

1) Proprietary Name	: TEETHMATE F-1
2) Common/Usual Name	: Pit and fissure sealant
3) Classification Name	: Pit and fissure sealant and conditioner

4. Similar Products

Following similar products are sold in US market.

1. TEETHMATE-F by Kuraray Co.,Ltd.
1. DELTON PLUS by Dentsply Ash
1. WHITE SEALANT LC by 3M Company
1. FLURO SHIELD by Dentsply
1. FLUORO BOND by ORMCO
1. HELIOSEAL by Vivadent(USA)

5. Description for the premarket notification

This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.

6. Statement of the intended use

This device is used as a sealing material for pit and fissure. This intended use is same to that of similar products which are identified in the paragraph 4.

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1. Statement of the technological characteristics
  This device is developed as a simplified material on handling of Kuraray's TEETHMATE-F This actived is doverspood by registration of its 510(k) number K910424. The willer was permitted to is a single-liquid type which is improved from the two-liquids type of TEETHMATE-F.

The chemical substances in the sealant resin other than TMDPO and HEMA are used in HEMA is used in the resin tooth bonding agent, C.F.R. section 872.3200, TEETHMATE-F. CLEARFIL LINER BOND 2 which was permitted to be marketed by registration of its 510(k) number K943170. TMDPO is used as a light-curing catalyst.

8. Summary of toxicity study

ullimary of whichly coad)
The ingredients in TEETHMATE F-1 other than TMDPO have been already used in Kuraray's I ho mgrouville allowed to be sold in US market. Therefore the biocompatibility of TMDPO the new ingredient TMDPO was evaluated its acute toxicity(LD 50), subacute toxicity and genotoxicity(Ames test).

The amount of leaching TMDPO from cured resin into distilled water and the acute toxicity of extracted fluid were evaluated.

These results suggest that TEETHMATE F-1 is a safe dental device.

Biological evaluation of TMDPO 8-1

8-1-1 Acute toxicity of TMDPO
- : Kuraray Co., Ltd. 1) Tested by
- 1. Animal : Mouse
- 1. Dosing Route : Oral
- : 10 days 4) Dosing period
- : LD50 ; over 4,000 mg/kg 5) Results

8-1-2 Subacute toxicity test

: The Kitasato Institute 1) Tested by
: Rat 2) Animal
: Oral (13mg/kg/day) 3) Dosing Route
: 25 days (5 days/week, 5 weeks) 4) Dosing period
1. Results : Negative

8-1-3 Genotoxicity test (Ames test)

: The Kitasato Institute 1) Tested by
1. Results : Negative

Bacterial species	Genotoxicity
	Directs test	Metabolic activity test
Escherichia coli WP2 uvrA	Negative	Negative
Salmonella typhimurium TA100	Negative	Negative
Salmonella typhimurium TA1535	Negative	Negative
Salmonella typhimurium TA98	Negative	Negative
Salmonella typhimurium TA1537	Negative	Negative

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8-2 Leachables

8-2-1 Amount of TMDPO leached from cured resin

The amount of leaching TMDPO cured resin was evaluated in Kuraray Co., Ltd.

1) Sample	: Cured resin 10mm $\phi$ × 5mm
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1. Extraction media : Distilled water
: Two pieces of cured resin were immersed into 20ml of distilled 3) Method water and stored at 37℃ or 50℃ for 24 hours. The amount of leached TMDPO in water was measured using high pressure liquid chromatography
: Less than identification limit (0.04ppm) for both conditions. 4) Results

8-2-2 Acute toxicity of Leachables

The acute toxicity of extraction fluid was evaluated in Kuraray CO.,LTD.

1) Sample	: Cylindrical specimens, 3mm $\phi$ ×3mm, of cured resin.
2) Extraction media	: Distilled water
3) Animal	: ICR mice
4) Route of administration	: Around 44 specimens were immersed into distilled water, in the ratio of 10ml/1g-specimen, and stored at 85°C for one hour. The extraction fluid was administrate amount was 20 ml/kg-mouse. After 7 days, weight change of each mouse was obtained.
5) Result	: The leachables from cured resin into water did not affect weight of mouse and no mouse died.

వ్యాస్య

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.