(120 days)
Not Found
No
The summary describes a dental adhesive system and an activator, focusing on chemical composition and curing properties. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is used for adhesion of dental filling materials, which is a restorative rather than therapeutic function.
No
The device is described as a system for adhesion of dental filling materials, not for diagnosing medical conditions.
No
The device description clearly indicates it is a chemical system (Dentin Conditioning and Adhesive System and Bond-1 Self Cure Activator) used for adhesion in dental procedures, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for adhesion to dentin and enamel for dental restorative procedures (bonding composites, metals, porcelain, glass). This is a direct application within the body (or on tissues within the body) for a therapeutic or restorative purpose.
- Device Description: The description reinforces the use of the product for bonding dental materials to tooth structure. The addition of the self-cure activator facilitates the curing process of the adhesive system, which is still a part of the dental restoration process.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of human specimens outside the body for diagnostic or monitoring purposes.
The device described is a dental adhesive system used for bonding restorative materials to tooth structure, which falls under the category of dental devices used for treatment and restoration, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1).
Product codes
KLE
Device Description
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel. Dentin Conditioning and Adhesive System (Bond-1) was approved by the FDA on September 12, 1997 under 510(k) # K973388.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, enamel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
21.0 510(K) SUMMARY
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel. Dentin Conditioning and Adhesive System (Bond-1) was approved by the FDA on September 12, 1997 under 510(k) # K973388.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.
Jeneric/Pentron, Inc. 510K Submission - Bond 1 C&B K013543
1
Image /page/1/Picture/1 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 symbol resembling three overlapping lines, possibly representing an abstract human figure or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2002
Ms. Annmarie Tenero Jeneric/Pentron, Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallinford, Connecticut 06492-0724
Re: K013542
Trade/Device Name: Dentin Conditioning and Adhesive System (Bond-1) Regulation Number: 872.3200 Regulation Name: Dental Adhesive System Regulatory Class: II Product Code: KLE Dated: December 3, 2001 Received: December 4, 2001
Dear Ms. Tenero:
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.
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.
2
Page 2 - Ms. Tenero
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613dditionally, 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). 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,
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
FEB 1 4 2002
6.0 EXECUTIVE SUMMARY
INDICATIONS FOR USE:
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various Denin Conditioning and Admosive Bystens (2) vith other conditioners or combination of polyment inning matchals (composites) acce 1. colding amalgam, gold, semi precious and conditioners for vollaning of composite to no luting of same to dentin and enamel. Dentin non precious andys, porcelan and glass and hang of the FDA on September 12, 1997 under 510(k) # K973388.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with We are additioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.
MODIFIED OR ENHANCED VERSION OF PREDICATE DEVICE:
MODIFIED OK ENIANCED TEXDICAL Cure Activator to be used in conjunction with we are adding a component cance Bone 7 Deli Carmula for Bond-1 Self Curre Activator is Dentin Conditioning and Adnesve Bystem. "The Activator, when mixed with Dentin Conditioning
attached in the application. Bond-1 Self Cure Activate the was of light allached in the application. "Dond T Bon Carol of C&B to cure with or without the use of light.
IDENTIFY ALL ACCESSORIES:
Robert wms for Dr. Susan Rummer
Division Sign-Off) വിഴിടിഠന ടിട്ടുന-ഠനം
Division of Dental, Infection Control, and General Hospital Devices 42 ් (උද්) Number -