(78 days)
Not Found
No
The device description focuses on the chemical composition and physical properties of a dental adhesive, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is an adhesive used for bonding dental materials, which is a restorative rather than therapeutic function.
No
Explanation: The device is an adhesive used for bonding dental materials; it does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device description clearly states it is a light-cured self-etching, self-priming adhesive with a specific chemical composition including filler material, 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:
- Intended Use: The intended use clearly states that the device is for "direct bonding of composite and compomer materials to enamel and dentin" and for "adhesive bonding of other dental materials". This describes a device used in vivo (within the body) for a dental restorative procedure.
- Device Description: The description details a "light-cured self-etching, self-priming adhesive" used in a dental setting. This aligns with a device used directly on a patient's teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue, for diagnostic purposes. The device's function is purely adhesive for dental restoration.
Therefore, the Generation 8 SE Adhesive product is a dental restorative material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.
Product codes
KLE
Device Description
The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared.
Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and 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)
A review for safety and effectiveness was performed and found not to have been affected.
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters. The characters appear to be "K072480". The characters are written in a cursive style, with some connections between the letters and numbers. The image has a white background.
Image /page/0/Picture/1 description: The image shows the logo for Pentron Clinical Technologies, LLC. The logo features the company name in a simple, sans-serif font, with the word "Pentron" appearing above "Clinical" and "Technologies, LLC" appearing below. To the left of the company name is a graphic element that resembles a stylized, abstract representation of a globe or sphere, composed of horizontal lines that gradually decrease in length from top to bottom.
NOV 2 1 2007
510(K) SUMMARY 6.0
Pentron Clinical Technologies, LLC. 68 North Plains Industrial Road Wallingford, CT 06492 203-265-7397 Tel: 203-284-4986 Fax: Contact: Greg Moreau
Trade Name: Generation 8 SE Adhesive Common Name: Bonding Agent Classification Name: Agent, Tooth Bonding, Resin, 21CFR 872.3200, KLE ==============================================================================================================================================================================
Generation 8 SE Adhesive product performs the same intended function as its predicate device, One Coat SE Bond (reference K033760) for direct bonding applications. Both devices are intended for direct bonding of composite materials to enamel or dentin as well as for adhesive bonding of other dental materials such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.
The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared.
Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
A review for safety and effectiveness was performed and found not to have been affected.
이트라이클램이 예술하다.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the seal is depicted with a modern, abstract design. The text is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2007
Mr. Greg Moreau Quality Systems Manager Pentron Clinical Technology, LLC 68 -70 North Plains Industrial Road Wallingford, Connecticut 06492
Re: K072480
Trade/Device Name: Generation 8 SE Adhesive Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 28, 2007 Received: September 4, 2007
Dear Mr. Moreau:
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.
2
Page 2 - Mr. Moreau
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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suan Luons
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
3
5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN):
Generation 8 SE Adhesive DEVICE NAME:
INDICATION FOR USE:
Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Joncurrence of CDRH, Office of Device Evaluation (ODE) | Comments of the consisted on the comments of the program and the program and the comments of the comments of the comments of the comments of the comments of the comments of t | |
|---|---|---|
Prescription Use (Per 21 CFR 801.109)
OR
Over -The-Counter-Use (Optional Format 1-2-96
Sise Sum
18: 8:20-09 ton of Anesthesiology, General Hospital, Con Control, Dent
510(k) Submission for Generation 8 SE Adhesive