(64 days)
Not Found
No
The device description and intended use relate to dental bonding agents and restorative materials, with no mention of AI or ML. The performance studies focus on material biocompatibility and leaching, not algorithmic performance.
No.
The device description and intended use indicate it is for dental restorations and bonding, which are not considered therapeutic actions.
No
Explanation: The device is a dental restorative material (resin tooth bonding agent and tooth shade resin material) used for filling cavities, bonding restorations, and treating hypersensitive root surfaces. It does not perform any diagnostic function.
No
The device description explicitly states it is composed of materials like dimethacrylate monomers and bisphenol A glycidylmethacrylate (Bis-GMA), which are physical substances, not software. The performance studies also focus on the biological evaluation and leaching of these chemical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's tooth (restorations, bonding, sealing, repairs, cementing). These are therapeutic and restorative actions, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a "resin tooth bonding agent" and "tooth shade resin material" intended to be applied to the tooth to improve retention of restorative materials or restore defects. This aligns with a dental material used in treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
- Regulatory Classification: The device is classified under CFR 21 Section 872.3200 (resin tooth bonding agent) and 872.3690 (tooth shade resin material), which are classifications for dental materials used in treatment, not IVDs.
In summary, the device's function, intended use, and regulatory classification clearly indicate it is a dental material used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is used for the following indications. Each indication is same as that of similar products.
- Direct filling restorations using light-cure or chemical-cure composite resin
- Bonded amalgam restorations
- Treatment of hypersensitive and/or exposed root surfaces
- Cavity sealing as a pretreatment for indirect restorations
- Intraoral repairs of facing crowns using light-cure composite resin
- Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
Product codes
KLE
Device Description
CLEARFIL LINER BOND 2V is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to marketed under its 510 (k) notification submission.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / teeth
Indicated Patient Age Range
Not Found
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 chemical ingredients excepting DMABB have been already used in Kuraray's dental material allowed to be sold in US market as described in the paragraph 7-2. The biocompatibility of DMABB was evaluated its acute toxicity (LD50), genotoxicity Additionally The amount of leaching DMABB from cured resin and sensitization. into distilled water is evaluated.
These results suggest that CLEARFIL LINER BOND 2V is a safe dental device.
Biological evaluation of DMABB:
Acute toxicity:
Animal: Mouse
Dosing route: Oral
Dosing period: 10 days
Results: LD50; not less than 4,000 mg/kg
Genotoxicity test:
Method: Ames mutagenicity test
Results: Negative for Salmonella typhimurium TA100, Salmonella typhimurium TA1535, Escherichia coli WP2 uvrA, Salmonella typhimurium TA98, Salmonella typhimurium TA1537, both with and without S-9 mix.
This test was based on ISO 10993-3 (1992-12-15), biological evaluation of medical devices-part 3.
Sensitization (maximization test):
Method: Maximization sensitization test
Results: Negative
This test was based on ISO 10993-10 (1995-3-15), biological evaluation on medical devices.
Leachables (Amount of DMABB leached from cured resin):
Sample: Cured resin 10mm φ×5 mm.
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 DMABB in measured using high pressure liquid chromatography.
Result: Less than identification limit (0.04ppm) for both conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acute toxicity: LD50; not less than 4,000 mg/kg
Leachables: Less than identification limit (0.04ppm)
Predicate Device(s)
K943170, K871636, K943165, K943167, K942493, K964525, K910860, unknown, K934690
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo with a stylized letter "K" at the top and the word "KURARAY" at the bottom. The letter "K" is formed by a thick, angular line that creates a geometric shape. The word "KURARAY" is written in a simple, sans-serif font.
KURARAY
12-39, 1-Chome, Umeda, Kita-ku, Osaka 530, JAF +81-6-348-2603 -6-348-2552
[CLEARFIL LINER BOND 2V]
JAN 2 9 1998
510(k) SUMMARY
1. Submitter
-
Kuraray Co., Ltd. Name 1) 1-12-39, Umeda, Kita-ku, Osaka 530, Japan
-
- Address 81(Japan)6-348-2603
-
- Telephone 81(Japan)6-348-2552
-
Facsimile 4)
-
Contact person 5)
-
Yoshinori Nagase Dental Material Department Medical Products Division December 2, 1997
-
- Date
2. Representing (Subsidiary of Kuraray Co., Ltd.)
- Kurarav America, Inc.
- Name 1) 30th FI. Metlife Buiding, 200 Park Avenue, New Address 2) York, NY 10166
- (212)986-2230 3) Telephone 4)
- (212)876-3543 Facsimile Koji Fujita
- Contact person 5) President
3. Name of Device
- Proprietary Name CLEARFIL LINER BOND 2V 1) 2) Classification Name Resin tooth bonding agent (21CFR 872.3200) Common/Usual Name Resin-based dental adhesive system 3)
4. Predicate devices:
| 1) | CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. | (K943170) |
|---|---|---|
| 2) | CLEARFIL PORCELAIN BOND by Kuraray Co., Ltd. | (K871636) |
| 3) | CLEARFIL PHOTO BOND by Kuraray Co., Ltd. | (K943165) |
| 4) | CLEARFIL NEW BOND by Kuraray Co., Ltd. | (K943167) |
| 5) | SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE | (K942493) |
| SYSTEM by 3M COMPANY | ||
| 6) | PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL | (K964525) |
| BONDING AGENT WITH ACTIVATOR by DENTSPLY | ||
| 7) | ALL-BOND 2 by BISCO, INC. | (K910860) |
| 8) | PROBOND by LD CAULK/DENTSPLY | unknown |
| 9) | OPTIBOND by KERR MFG.CO | (K934690) |
1
5. Description for the premarket notification
CLEARFIL LINER BOND 2V is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to marketed under its 510 (k) notification submission.
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 for the following indications. Each indication is same as that of similar products.
-
- Direct filling restorations using light-cure or chemical-cure composite resin
| 1) | ||
|---|---|---|
| Direct filling restorations using light-cure or chemical-cure composite resin | ||
| a) CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. | (K943170) | |
| b) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. | (K943165) | |
| c) CLEARFIL NEW BOND by Kuraray Co., Ltd. | (K943167) | |
| d) SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE | ||
| SYSTEM by 3M COMPANY. | (K942493) | |
| e) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL | ||
| BONDING AGENT WITH ACTIVATOR by DENTSPLY | (K964525) | |
| f) ALL-BOND 2 by BISCO, INC. | (K910860) | |
| g) PROBOND by LD CAULK/DENTSPLY | unknown | |
| h) OPTIBOND by KERR MFG.CO | (K934690) | |
| 2) | ||
| Bonded amalgam restorations | ||
| a) CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. | (K943170) | |
| b) CLEARFIL PHOTO BOND by Kuraray Co., Ltd. | (K943165) | |
| c) CLEARFIL NEW BOND by Kuraray Co., Ltd. | (K943167) | |
| d) ALL-BOND 2 by BISCO, INC. | (K910860) | |
| e) PROBOND by LD CAULK/DENTSPLY | unknown | |
| f) OPTIBOND by KERR MFG.CO | (K934690) | |
| 3) | ||
| Treatment of hypersensitive and/or exposed root surfaces | ||
| a) CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. | (K943170) | |
| b) ALL-BOND 2 by BISCO, INC. | (K910860) | |
| 4) | ||
| Cavity sealing as a pretreatment for indirect restorations | ||
| a) ALL-BOND 2 by BISCO, INC. | (K910860) | |
| b) OPTIBOND by KERR MFG.CO | (K934690) |
2
(K934690)
- Intraoral repairs of facing crowns using light-cure composite resin
| a) | CLEARFIL PORCELAIN BOND by Kuraray Co., Ltd. | (K871636) |
|---|---|---|
| b) | SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE | |
| SYSTEM by 3M COMPANY. | (K942493) | |
| c) | PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL | |
| BONDING AGENT WITH ACTIVATOR by DENTSPLY | (K964525) | |
| d) | PROBOND by LD CAULK/DENTSPLY | unknown |
| e) | ALL-BOND 2 by BISCO, INC. | (K910860) |
| f) | OPTIBOND by KERR MFG.CO | (K934690) |
- Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
| a) SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE (K942493) | |
|---|---|
| SYSTEM by 3M COMPANY. | |
| b) PROBOND by LD CAULK/DENTSPLY | unknown |
|---|---|
| c) ALL-BOND 2 by BISCO, INC. | (K910860) |
OPTIBOND by KERR MFG.CO d)
- Statement of the technological characteristics and safety This device is developed as a improved material of CLEARFIL LINER BOND 2 (K943170).
Components 7-1.
The new component, BOND Liquid B, is used as a mixture with BOND Liquid A to enable the practitioner to use self-cure or dual-cure techniques. The etching agent and the porcelain primer are introduced to use for special intended purpose. These components are same components in the CLEARFIL PHOTO BOND (K943165) and CLEAFIL PORCELAIN BOND (K871636).
Chemical ingredients 7-2.
The chemical ingredients excepting DMABB have been already used in the following devices sold in the U.S. market. All of them are manufactured by Kuraray Co., Ltd.
- a) CLEARFIL LINER BOND 2 (K943170)
- b) PANAVIA 21(K933030) classified into the dental cement other than zinc oxideeugenol (21 CFR 872.3275(b))
- c) CLEARFIL PHOTO BOND (K943165)
- d) CLEARFIL PORCELAIN BOND (K871636)
- Summary of toxicity study 8.
The chemical ingredients excepting DMABB have been already used in Kuraray's dental material allowed to be sold in US market as described in the paragraph 7-2. The biocompatibility of DMABB was evaluated its acute toxicity (LD50), genotoxicity Additionally The amount of leaching DMABB from cured resin and sensitization. into distilled water is evaluated.
These results suggest that CLEARFIL LINER BOND 2V is a safe dental device.
3
8-1 Biological evaluation of DMABB
8-1-1 Acute toxicity
- Mouse 1) Animal
- Dosing route Oral 2)
- Dosing period 10 days 3)
- LD50; not less than 4,000 mg/kg 4) Results
Negative
8-1-2 Genotoxicity test
-
- Method Ames mutagenicity test
- Results 2)
| Bacterial species | Genotoxicity | |
|---|---|---|
| with S-9 mix | without S-9 mix | |
| Salmonella typhimurium TA100 | Negative | Negative |
| Salmonella typhimurium TA1535 | Negative | Negative |
| Escherichia coli WP2 uvrA | Negative | Negative |
| Salmonella typhimurium TA98 | Negative | Negative |
| Salmonella typhimurium TA1537 | Negative | Negative |
This test was based on ISO 10993-3 (1992-12-15), biological evaluation of medical devices-part 3.
8-1-3 sensitization (maximization test)
- Maximization sensitization test 1) Method
- Results Negative 2)
This test was based on ISO 10993-10 (1995-3-15), biological evaluation on medical devices.
8-2 Leachables
8-2-1 Amount of DMABB leached from cured resin
-
- Sample Cured resin 10mm φ×5 mm.
- Extraction media Distilled water 2)
- Two pieces of cured resin were immersed into 20ml of Method 3) distilled water and stored at 37℃ or 50℃ for 24 hours. The amount of leached DMABB in measured using high pressure liquid chromatography.
-
- Result Less than identification limit (0.04ppm) for both conditions
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 1998
Mr. Koji Fujita ·President Kuraray America, Incorporated 200 Park Avenue New York, New York 10166
Re: K974486 Trade Name: Clearfil Liner Bond 2V Requlatory Class: II Product Code: KLE Dated: November 25, 1997 Received: November 26, 1997
Dear Mr. Fujita:
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 of the Act. The general controls provisions 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 General regulation (21 CFR Part 820) and that, Devices: 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
5
Page 2 - Mr. Fujita
through 542 of the Act for devices under the Electronic enrough Siz on 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 diaqnostic 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.fida.gov/cdrh/dsmamain.html".
Sincerely yours,
Us. Aulatal
Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number(if known): Device Name: CLEARFIL LINER BOND 2V Indications For Use
-
- Direct filling restorations using light-cure or chemical-cure composite resin
-
- Bonded amalgam restorations
-
- Treatment of hypersensitive and/or exposed root surfaces
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Intraoral repairs of facing crowns using light-cure composite resin
-
- Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Renner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | Ka94456 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801 109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)