(7 days)
BC Plus™ is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.
BC Plus™ is a single component bonding agent designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam. BC Plus™ is an ethanol based formulation of light-activated, adhesive resin.
The provided 510(k) summary for the Vericom Co. Ltd. BC Plus™ device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Kaazaas) rather than presenting detailed performance data against specific acceptance criteria. The document states that the device "has been subjected to extensive safety, performance, and product validations prior to release," but it does not elaborate on these validations, their results, or the acceptance criteria used.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. All other requested details related to a specific performance study (sample size, data provenance, expert-established ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and training set ground truth establishment) are also absent from this submission.
Summary of missing information based on the prompt's request:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on substantial equivalence based on similar material, design, and use concept to the predicate device.
- Sample size used for the test set and the data provenance: Not present. No specific test set or study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is a resin tooth bonding agent, not an AI/algorithm-based device.
- The type of ground truth used: Not present.
- The sample size for the training set: Not applicable (not an AI/algorithm device), and no training data for general device performance is mentioned.
- How the ground truth for the training set was established: Not applicable.
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0011
Vericom Co. Ltd.
Healthy and beautiful teeth with Vericom
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Nov.24, 2004
-
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | VERICOM Co., Ltd. |
| Address | #606, 5th Dongyoung Venturestel199-32, Anyang 7-Dong, Manan-GuAnyang-Si, Gyeonggi-Do,Republic of Korea 430-817 |
| Phone | +82 31 441-2881 |
| Fax | +82 31 441-2883 |
| Contact | Myung-Hwan Oh |
| Internet | mh-oh@hanmail.net |
2. Device :
Proprietary Name - BC Plus™ Common Name - Resin Tooth Bonding Agent Classification Name - Agent, Tooth Bonding, Resin 21CFR 872.3200, KLE, Class2
- Predicate Device :
Kaazaas
-
- Description :
BC Plus™ is a single component bonding agent designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam. BC Plus™ is an ethanol based formulation of light-activated, adhesive resin.
- Description :
-
- Indication for use :
BC Plus™ is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.
- Indication for use :
606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/0/Picture/19 description: The image shows the logo for Vericom Dental Materials. The logo is a black curved shape with the word "VERICOM" in white letters inside. Below the curved shape, the words "Dental materials" are written in a smaller font.
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Healthy and beautiful teeth with Vericom
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- Contra-indications :
BC Plus™ should not be used with patients who develop hypersensitivity to it or have a history of hypersensitivity to methacrylate monomer.
- Contra-indications :
1 - .
-
- Review :
BC Plus™ has the same device characteristics as the predicate device. Material, design and use concept is similar.
- Review :
BC Plus™ has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of resin tooth bonding agent has been conducted. Appropriate safeguards have been incorporated in the design of BC Plus™
-
- Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification Vericom Co., Ltd. concludes that BC Plus™ is safe and effective and substantially equivalent to predicate devices as described herein. ﺎ
- Conclusions :
-
- Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
r :
Image /page/1/Picture/15 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in a stylized, curved font, positioned above the words "Dental materials" in a smaller, simpler font. The logo is black and white.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing shapes. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2005
Vericom Company Limited C/O Mr. Chan Yo Won Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K043562
Trade/Device Name: BC Plus™ Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 3, 2004 Received: December 27, 2004
Dear Mr. Won:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Won
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 mean that 1 27 mas muss statutes and regulations administered by other Federal agencies. or the rive of any I vath all the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT art 007), aquality systems (QS) regulation (21 CFR Part 820); and if requirelate as 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) I mo leter notification. The FDA finding of substantial equivalence of your device to a premaired 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), If you desite specifical of Compliance at (240) 276-0115. 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 from the may overnit 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,
Quite y. Mchiee m.D.
Chiu Lin. Ph.D. Director
DR. CHILL LIN
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K 0 4 3562
Device Name: BC Plus™
Indication for use:
BC Plus™ is a light curing single component bonding agent specially developed as a restorative adhesive in dentistry, which is used for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.
Over-The-Counter Use OR Prescription Use (Per 21CFR801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MEad, the MSR
(Civision Sigh-Off) Division of Anesthesiology, General Hospital,
Intection of Anesthesiology, General Hospital, Intection of Anesthesiology, Intection Control, De
:10(k) Number: K043562
§ 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.