(41 days)
K#974202, K#915668, K#832497, K#925375
K#023842, K#924982
No
The summary describes a resin-based dental adhesive with an antibacterial ingredient. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a dental adhesive system used for various applications in dentistry, but its primary function is not to cure or alleviate a disease or medical condition. Its "antibacterial cavity cleansing effect" is a secondary application within its primary role as an adhesive.
No
The device is a dental adhesive system used for various restorative and protective applications, not for diagnosing medical conditions.
No
The device description explicitly states it is a "resin-based dental adhesive system" and includes a specific chemical ingredient (MDPB), indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for CLEARFIL PROTECT BOND are all related to direct application within the mouth for dental procedures (restorations, sealing, treating surfaces, etc.). It is not used to analyze blood, urine, tissue, or other bodily fluids or substances in vitro (outside the body).
- The device description and intended uses clearly indicate a therapeutic and restorative function. It's a dental adhesive system used to bond materials and provide antibacterial effects within the oral cavity.
- The predicate and reference devices are also dental products. The listed K numbers correspond to dental cavity cleansers and bonding agents, not IVD devices.
Therefore, CLEARFIL PROTECT BOND is a dental device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the antibacterial ingredient, 12-methacryloyloxydodecylpyridinium bromide (MDPB), as fully disclosed in the original filing for the device K#023842 (under the name CLEARFIL SE BOND PLUS). No changes are being made to the composition of the device. The only purpose of this 510(k) filing is to add the claim that the device also has an "antibacterial cavity cleansing effect."
The CLEARFIL PROTECT BOND device is indicated for the following applications:
- direct restorations using light-cured composite resin or compomer
- cavity sealing as a pretreatment for indirect restorations
- treatment of hypersensitive and/or exposed root surfaces
- intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
- surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
- core build-ups using light- or dual-cured composite resin
- cavity sealing under amalgam restorations
- For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
Product codes (comma separated list FDA assigned to the subject device)
76KLE, KLE, LBH
Device Description
CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the antibacterial ingredient, 12-methacryloyloxydodecylpyridinium bromide (MDPB).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Substantial safety and efficacy testing has been conducted on the device, and specifically of the ingredient MDPB. Testing shows MDPB to be biocompatible, and also an effective antibacterial cavity cleanser compared to control groups of dental resin material without MDPB.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#974202, K#915668, K#832497, K#925375
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K#023842, K#924982
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 2 9 2004
510(k) SUMMARY Kuraray Medical Inc. CLEARFIL PROTECT BOND
Name of Device
Trade or Proprietary Name: Common Name: Classification Name: Product Code:
CLEARFIL PROTECT BOND resin-based dental adhesive system resin tooth bonding agent 76KLE
Preparation Date
December 11, 2003
510(k) Sponsor
Kuraray Medical Inc. 1621 Sakazu, Kurashiki, Okayama 710-8622 Japan
510(k) Sponsor Contact
Mr. Koji Nishida Kuraray America, Inc. 101 East 52"d Street 26th Floor New York, NY 10022 Phone: 800-879-1676 Fax: 888-700-5200
Intended Use
CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the antibacterial ingredient, 12-methacryloyloxydodecylpyridinium bromide (MDPB), as fully disclosed in the original filing for the device K#023842 (under the name CLEARFIL SE BOND PLUS). No changes are being made to the composition of the device. The only purpose of this 510(k) filing is to add the claim that the device also has an "antibacterial cavity cleansing effect."
1
Technological Characteristics and Substantial Equivalence
CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the new antibacterial ingredient 12-methacryloyloxydodecylpyridinium bromide (MDPB), as fully disclosed in the original filing for the device K#023842 (under the name CLEARFIL SE BOND PLUS). No changes are being made to the composition of the device. The only purpose of this 510(k) filing is to add the claim that the device also has an "antibacterial cavity cleansing effect."
Substantial safety and efficacy testing has been conducted on the device, and specifically of the ingredient MDPB. Testing shows MDPB to be biocompatible, and also an effective antibacterial cavity cleanser compared to control groups of dental resin material without MDPB.
CLEARFIL PROTECT BOND is substantially equivalent for purposes of FDA market authorization to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#924982). Although the CLEARFIL PROTECT BOND device has a different antibacterial ingredient (MDPB), the biocompatibility studies submitted with K#023842 demonstrate the safety of MDPB, and the efficacy studies submitted herewith demonstrate its effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be three overlapping lines or strokes, possibly representing a human form or abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2004
Kuraray Medical, Incorporated C/O Mr. Keith A. Barritt, Esq. Attorney Fish & Richardson P.C. 1425 K Street, N.W. Washington, District of Columbia 20005
Re: K033938
Trade/Device Name: CLEARFIL PROTECT BOND Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and LBH Dated: December 18, 2003 Received: December 22, 2003
Dear Mr. Barritt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasin a reasy for any for any and and and if the referenced above and have determined are to tegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that been reclassified in accordance with the for wreating Amendinens, of to devices that hart e est (Act) that do not require approval of a premarket the Federal Food, Drug, and Ocombile : 100 crefore, market the device, subject to the general approval application (1 Mr.). - The general controls provisions of the Act include controls provisions of the real - 110 gisting 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 if your device is classified (see above) into exactives. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the ecas nouncements concerning your device in the Ecderal Register.
3
Page 2 - Mr. Keith A. Barritt, Esq.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tim S. Liao, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
K033939 510(k) Number (if known): Device Name: CLEARFIL PROTECT BOND Indications For Use:
The CLEARFIL PROTECT BOND device is indicated for the following applications:
l ) direct restorations using light-cured composite resin or compomer
-
cavity sealing as a pretreatment for indirect restorations
-
treatment of hypersensitive and/or exposed root surfaces
-
intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
-
surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
-
core build-ups using light- or dual-cured composite resin
-
cavity sealing under amalgam restorations
** For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
(DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Dunne
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K003938