(71 days)
Not Found
No
The summary describes a dental adhesive system and does not mention any AI or ML components or functionalities.
No
This device is an adhesive system used for bonding dental materials, not for therapeutic purposes like treating a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as an "adhesive system" used for bonding dental materials. It does not mention any function related to diagnosing diseases, conditions, or injuries.
No
The device description clearly states it is a "light-cured, reinforced dentin bonding agent" provided in a kit with physical components (primer, adhesive, activator). This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in bonding dental materials to tooth structure (dentin and enamel). This is a direct application within the body (or on a part of the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a light-cured adhesive system used for bonding. This aligns with a dental restorative material, not a diagnostic test kit.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in a sample
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
Therefore, the Nano-Bond II Adhesive System is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.
Product codes
KLE, EMA
Device Description
Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.
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
K071500
510(k) Summary
Nano-Bond II Adhesive System
AUG 1 0 2007
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Pentron Clinical Technologies, LLC
53 North Plains Industrial Road
Wallingford, CT 06492
Telephone 1 (203) 303-2280
Fax 1 (203) 284-4986 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Greg Moreau |
| Representative/Consultant: | Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130
Telephone 1 (858) 792-1235
Fax 1 (858) 792-1236
email: flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Name: Classification Regulations : Product Codes: Classification Panel: Reviewing Branch:
Nano-Bond II Adhesive System Resin, dental cement Resin tooth bonding agent, dental cement (21 CFR 872.3200, 872.3275) Class II KLE, EMA Dental Products Dental Devices
ESTABLISHMENT REGISTRATION
Establishment Registration Number: 3003690896 Owner/Operator Number: 9050352
INTENDED USE
Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.
1
DEVICE DESCRIPTION
Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.
EQUIVALENCE TO MARKETED PRODUCT
Pentron Clinical Technologies, LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Nano-Bond II Adhesive System is substantially equivalent in indications and design principles to the following predicate device which has been determined by FDA to be substantially equivalent to preamendment devices: Nano Bond (Bond-3 Adhesive) (K020499) from Jeneric/Pentron, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pentron Clinical Technologies, LLC C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
AUG 1 0 2007
Re: K071500
Trade/Device Name: Nano-Bond II Adhesive System Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE, EMA Dated: May 25, 2007 Received: May 31, 2007
Dear Mr. Larson:
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.
3
Page 2 - Mr. Larson
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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ques
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K071500
Device Name: Nano-Bond II Adhesive System
Indications for Use:
Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K071507 |
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