TEETHMATE F-1

• K Number: K965091
• Device Name: TEETHMATE F-1
• Manufacturer: KURARAY COMPANY, LTD.
• Date Cleared: 1997-03-27 ( 98 days)
• Product Code: EBC
• Regulation Number: 872.3765

Intended Use

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

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.

Predicate Devices

K910424, K943170

Reference Devices

K910424, K943170

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material composition and biocompatibility of a pit and fissure sealant, with no mention of AI or ML technology.

Therapeutic

Yes
The device is described as "a device composed of resin...intended for use...to seal pit and fissure depressions in the biting surfaces of teeth to present cavities," which is a preventative health measure, fitting the definition of a therapeutic device.

Diagnostic

No
The device is described as a sealant for pit and fissure, intended to prevent cavities, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "device composed of resin" and is used as a "sealing material," indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to seal pits and fissures in teeth to prevent cavities. This is a direct treatment/preventative measure applied to the patient's body.
• Device Description: The description clearly states it's a pit and fissure sealant, a type of dental device applied to the tooth surface.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

Not Found

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.
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.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth

Indicated Patient Age Range

young children

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of toxicity study: The biocompatibility of TMDPO, a new ingredient, was evaluated for 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:
Acute toxicity of TMDPO:
Tested by: Kuraray Co., Ltd.
Animal: Mouse
Dosing Route: Oral
Dosing period: 10 days
Results: LD50 ; over 4,000 mg/kg

Subacute toxicity test:
Tested by: The Kitasato Institute
Animal: Rat
Dosing Route: Oral (13mg/kg/day)
Dosing period: 25 days (5 days/week, 5 weeks)
Results: Negative

Genotoxicity test (Ames test):
Tested by: The Kitasato Institute
Results: Negative

Bacterial species	Genotoxicity (Directs test)	Genotoxicity (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

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

Acute toxicity of Leachables:
Sample: Cylindrical specimens, 3mm φ ×3mm, of cured resin.
Extraction media: Distilled water
Animal: ICR mice
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.
Result: The leachables from cured resin into water did not affect weight of mouse and no mouse died.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K910424, K943170

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

[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

2. 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 : [phone] : [phone]
• 4. 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.
• 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

• 7. 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
  • 2. Animal : Mouse
  • 3. 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
• 5. Results : Negative

8-1-3 Genotoxicity test (Ames test)

• : The Kitasato Institute 1) Tested by
• 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

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
-----------	---------------------------------

• 2. 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.

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