TEETHMATE F-1

K965091 · Kuraray Company, Ltd. · EBC · Mar 27, 1997 · Dental

Device Facts

• Record ID: K965091
• Device Name: TEETHMATE F-1
• Applicant: Kuraray Company, Ltd.
• Product Code: EBC · Dental
• Decision Date: Mar 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is used as a sealing material for pit and fissure.

Device Story

TEETHMATE F-1 is a single-liquid, light-cured pit and fissure sealant. It is applied by dental professionals to the occlusal surfaces of teeth to create a physical barrier against caries. The device utilizes a light-curing catalyst (TMDPO) to initiate polymerization of the resin upon exposure to a dental curing light. It is intended for clinical use in a dental office setting. By sealing susceptible pits and fissures, the device prevents the accumulation of food and bacteria, thereby reducing the incidence of dental cavities in pediatric patients.

Clinical Evidence

Bench testing only. Biocompatibility evaluation included acute oral toxicity (LD50 > 4,000 mg/kg in mice), subacute oral toxicity (negative in rats at 13mg/kg/day), and genotoxicity (Ames test negative across multiple strains). Leachable analysis using HPLC showed TMDPO leaching from cured resin was below the identification limit (0.04ppm). Acute toxicity of leachables in mice showed no adverse weight change or mortality.

Technological Characteristics

Single-liquid, light-cured resin sealant. Contains polymethyl methacrylate, HEMA, and TMDPO (light-curing catalyst). Polymerization initiated via light-curing. Formulated as a simplified, single-component version of the predicate two-liquid system.

Indications for Use

Indicated for use primarily in young children to seal pit and fissure depressions in the biting surfaces of teeth to prevent cavities.

Regulatory Classification

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.

Predicate Devices

• TEETHMATE-F (K910424)

Reference Devices

• DELTON PLUS (Dentsply Ash)
• WHITE SEALANT LC (3M Company)
• FLURO SHIELD (Dentsply)
• FLUORO BOND (ORMCO)
• HELIOSEAL (Vivadent(USA))
• CLEARFIL.LINER BOND 2 (K943170)

Submission Summary (Full Text)

{0}

K965091

[TEETHMATE F-1, Kuraray]

MAR 27 1997

# KURARAY CO., LTD.

1-12-39, Umeda, Kita-ku, Osaka 530, Japan

# 510(K) SUMMARY

## 1. Submitter

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

## 2. Representing (Subsidiary of Kuraray Co., Ltd.)

1) Name : Kuraray America Inc.
2) Address : 30th FI. Metlife Building, 200 Park Avenue, New York, NY 10166
3) Telephone : [phone]
4) Facsimile : [phone]
5) Contact person : Koji Fujita
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.
2) DELTON PLUS by Dentsply Ash
3) WHITE SEALANT LC by 3M Company
4) FLURO SHIELD by Dentsply
5) FLUORO BOND by ORMCO
6) HELIOSEAL by Vivadent(USA)

## 5. Description for the premarket notification

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.

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.

{1}

[TEETHMATE F-1, Kuraray]

## 7. Statement of the technological characteristics

This device is developed as a simplified material on handling of Kuraray's TEETHMATE-F which was permitted to be marketed by registration of its 510(k) number K910424. The sealant resin of this device 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 TEETHMATE-F. HEMA is used in the resin tooth bonding agent. C.F.R. section 872.3200, 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

The ingredients in TEETHMATE F-1 other than TMDPO have been already used in Kuraray's dental materials 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.

## 8-1 Biological evaluation of TMDPO

### 8-1-1 Acute toxicity of TMDPO

1) Tested by : Kuraray Co., Ltd.
2) Animal : Mouse
3) Dosing Route : Oral
4) Dosing period : 10 days
5) Results : LD50 ; over 4,000 mg/kg

### 8-1-2 Subacute toxicity test

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

### 8-1-3 Genotoxicity test (Ames test)

1) Tested by : The Kitasato Institute
2) 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 |

{2}

[TEETHMATE F-1, Kuraray]

## 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 $\phi \times 5\mathrm{mm}$
2) Extraction media : Distilled water
3) Method : Two pieces of cured resin were immersed into 20ml of distilled water and stored at $37^{\circ}\mathrm{C}$ or $50^{\circ}\mathrm{C}$ for 24 hours. The amount of leached TMDPO in water was measured using high pressure liquid chromatography
4) Results : Less than identification limit (0.04ppm) for both conditions.

### 8-2-2 Acute toxicity of Leachables

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

1) Sample : Cylindrical specimens, 3mm $\phi \times 3\mathrm{mm}$, 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 $10\mathrm{ml} / 1\mathrm{g}$-specimen, and stored at $85^{\circ}\mathrm{C}$ for one hour. The extraction fluid was administrate amount was $20\mathrm{ml} / \mathrm{kg}$-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.