(64 days)
- 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
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.
The provided text is a 510(k) Pre-Market Notification for a dental adhesive system, CLEARFIL LINER BOND 2V. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and detailed device performance outcomes against those criteria in the way a novel medical device might.
Therefore, the requested information categories (1-9) which are typically used to describe the acceptance criteria and study proving device performance for a novel device, are largely not applicable in the context of this 510(k) submission.
Here's an analysis of why and what information is available:
First, understanding the context:
- 510(k) Submission: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as, i.e., "substantially equivalent" to, a legally marketed predicate device. It does not require clinical trials to establish new safety and efficacy, but rather to show that the new device does not raise different questions of safety and effectiveness than the predicate device.
- Predicate Device: CLEARFIL LINER BOND 2V is being compared to several predicate devices, with CLEARFIL LINER BOND 2 (K943170) being the primary one mentioned for technological improvement.
Let's address each point based on the provided text:
-
A table of acceptance criteria and the reported device performance
- Not Applicable in this context. For a 510(k), specific "acceptance criteria" for clinical performance (e.g., a certain sensitivity/specificity threshold) are generally not established in the same way as for a novel device requiring new efficacy data. Instead, the focus is on showing equivalence in composition, function, and intended use, often supported by bench testing and biocompatibility.
- The document primarily describes a biocompatibility study for a new chemical ingredient (DMABB), not a clinical performance study against specific acceptance criteria.
- Reported performance (Biocompatibility of DMABB):
Test Type Acceptance Criteria (Implied) Reported Device Performance Acute Toxicity (LD50) No significant toxicity at doses relevant to exposure. Not less than 4,000 mg/kg (Mouse, Oral, 10 days) - Negative Genotoxicity No mutagenic effects. Negative (Ames test, 5 bacterial species, with/without S-9 mix) Sensitization No evidence of allergic or hypersensitivity reactions. Negative (Maximization Sensitization Test) Leachables (DMABB) Amount leached should be below toxicologically relevant levels. Less than identification limit (0.04 ppm) in distilled water (at 37℃ and 50℃ for 24 hours)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Acute Toxicity: Mouse (number not specified, but typically a group for dose-response).
- Genotoxicity: Not applicable, as this is a laboratory test on bacterial cultures.
- Sensitization: Not applicable, as this is a laboratory test, likely on animals (e.g., guinea pigs for maximization test), but the count is not specified.
- Leachables: "Two pieces of cured resin" were used.
- Data Provenance: Not explicitly stated, but assumed to be from internal Kuraray studies, likely conducted in Japan (the submitter's country). The studies are prospective in nature for these specific tests.
- Test Set Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For biocompatibility and chemical leachable studies, ground truth is established through standardized laboratory methods (e.g., ISO standards, Ames test procedures, HPLC analysis) and observed biological responses, not an expert panel.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or complex clinical endpoints. For the objective, quantitative lab tests described (LD50, genotoxicity, sensitization, leachable quantification), no adjudication method is used.
-
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 device is a dental adhesive, not an AI-powered diagnostic tool requiring human reader studies.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a dental adhesive, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for Biocompatibility/Chemical Tests:
- Acute Toxicity: Live animal response (survival, clinical signs) to a chemical dose.
- Genotoxicity: Presence/absence of mutations in bacterial strains, assessed against negative and positive controls.
- Sensitization: Dermal reactions in test subjects/animals.
- Leachables: Quantitative chemical analysis (High Pressure Liquid Chromatography - HPLC) for the presence and concentration of DMABB.
- Ground Truth for Biocompatibility/Chemical Tests:
-
The sample size for the training set
- Not Applicable. No machine learning or AI is involved in this device, so there is no "training set."
-
How the ground truth for the training set was established
- Not Applicable. As no training set exists, this question is irrelevant.
Summary for this 510(k) Submission:
The provided document details a 510(k) submission, whose primary goal is to demonstrate substantial equivalence to existing predicate devices. Therefore, it focuses on comparing the new device's composition, intended use, and technological characteristics to those of legally marketed devices.
The "study that proves the device meets the acceptance criteria" in this context refers to biocompatibility testing conducted on a new chemical ingredient (DMABB) introduced in CLEARFIL LINER BOND 2V, which was not present in previously approved Kuraray products. These tests (acute toxicity, genotoxicity, sensitization, and leachable analysis) aim to show that this new ingredient does not pose new safety concerns, thereby supporting the overall substantial equivalence of the new device to its predicates. The "acceptance criteria" are generally implied by the negative results, indicating the absence of adverse toxicological effects or leachable levels above identification limits, consistent with standard biocompatibility assessments for medical devices.
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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 ADHESIVESYSTEM by 3M COMPANY. | (K942493) | |
| e) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMELBONDING 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 ADHESIVESYSTEM by 3M COMPANY. | (K942493) |
| c) | PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMELBONDING 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
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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)
§ 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.