(56 days)
Gluma One Bond, Optibond Solo Plus, Optibond Solo Plus 2, Clearfil SE Bond, Touch&Bond
Not Found
No
The 510(k) summary describes a chemical bonding agent and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a bonding agent used in dental restorative procedures and for desensitizing teeth, not for treating a disease or condition in a therapeutic sense.
No
The provided text describes the device as a "dentin bonding agent" and a "bonding system" used for various dental restorations and treatments, such as filling materials, cementing restorations, and treating hypersensitive areas. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly states it is a "Single bottle, self-etching, self-priming, light-cured bonding system" which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a dental material applied directly to tooth surfaces and exposed dentin. It is used for bonding restorations, treating hypersensitivity, and sealing cavities. These are all procedures performed in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
The information provided describes a dental adhesive and sealant, which is a medical device used in the mouth, not an IVD.
N/A
Intended Use / Indications for Use
This material is indicated for the following:
- A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
- A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored and cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc.
- Treatment of hypersensitive areas of exposed root surfaces.
- A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.
Product codes
KLE
Device Description
Single bottle, self-etching, self-priming, light-cured bonding system that contains 4-META. Does not require acid etching of tooth surfaces, and can be polymerized with any available light-cure device. For use as the adhesive agent for direct or indirect restorations, and can be used as a sealant/desensitizer to minimize post-operative sensitivity,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surfaces, exposed root surfaces, dentin
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)
Gluma One Bond, Optibond Solo Plus, Optibond Solo Plus 2, Clearfil SE Bond, Touch&Bond
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
MAR 2 0 2002
510(k) SUMMARY
Parkeil, Inc. Submitter: 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: 631-249-1134 FAX: 631-249-1242 Nalson J. Gendusa, DDS Contact: Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 15 January 2002 Submission Date: Touch&Bond-Plus Trade Name; Dentin Bonding System Common Name; Resin Tooth Bonding Agent Classification Name: Gluma One Bond, Optibond Solo Plus, Optibond Solo Equivalence: Plus 2, Clearfil SE Bond, Touch&Bond. Single bottle, self-etching, self-priming, light-cured bond-Description/Intended Use;
ing system that contains 4-META. Does not require acid etching of tooth surfaces, and can be polymerized with any available light-cure device. For use as the adhesive agent for direct or indirect restorations, and can be used as a sealant/desensitizer to minimize post-operative sensitivity,
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, arranged in a stacked formation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
Dr. Nelson J. Gendusa Director of Research Parkell, Incorporation 155 Schmitt Boulevard Farmingdale, New York 11735
Re: K020239
Trade/Device Name: Touch&Bond-Plus Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 18, 2002 Received: January 23, 2002
Dear Dr. Gendusa:
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 - Dr. Gendusa
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Pice b roqu21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Pat 820) 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 I his letter will anow you to ocgin manoling of substantial equivalence of your device to 310(K) premiation notheation: "The 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 IT you desire specific ac not 10: your your vitro diagnostic devices), please contact the and additionally 21 CLR Part 609110 103. Additionally, for questions on the promotion and Office of Colliphance at (301) 89 contact the Office of Compliance at (301) 594-4639. advertising or Jour ar a regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nothication (ZTCI K Furt 007.97). Sales got Small Manufacturers, International and the Act may be obtained them and Boumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patron Cuscattiffor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page ____ of _l
| 510(k) Number (if known): | K020239 |
|---|---|
| Device Name: | TOUCH&BOND-PLUS |
Indications for Use: This material is indicated for the following:
- A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
- A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored and cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc.
- Treatment of hypersensitive areas of exposed root surfaces.
- A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.
Susan Renner
(Division Sign-Off) piration of Dental, Infection Control,
Division of Dental, Infection Control,
and General Hosspital Devices
510(k) Number ___________________________________________________