(39 days)
No
The document describes a dental adhesive system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an adhesive system used for dental restorations and bonding, not for treating or preventing disease.
No
Explanation: The device description and intended use indicate that XENO® ADHESIVE WITH ACTIVATOR is an adhesive system used for bonding various dental restorations. It does not describe any function related to diagnosing diseases or conditions.
No
The device description clearly states it is a "dual-cure, self-etch, two-component adhesive system," which are physical components (liquids/chemicals) used in dental procedures, 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 describes the device's function in bonding dental restorations and materials to teeth. This is a direct application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description details a dental adhesive system used for bonding, which aligns with its in-vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information about a patient's health condition.
Therefore, XENO® ADHESIVE WITH ACTIVATOR is a dental device used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
XENO® ADHESIVE WITH ACTIVATOR is indicated for:
- direct, light-cured composite and compomer restorations; .
- indirect restorations; .
- light-cured resin cemented veneers; .
- composite, ceramic, and amalgam repairs; .
- cavity varnish for use with fresh amalgam; .
- Cavity varmsil for asself-cure composite restorations and core build-ups; .
- unfect, dual-cure of sen care compoon and bridge retainers, and endodontic post . cementation; and .
- adhesive bonding of direct amalgam restorations. .
Product codes
KLE
Device Description
XENO® ADHESIVE WITH ACTIVATOR is a dual-cure, self-etch, two-component adhesive system. It utilizes the same XENO® adhesive found in the predicate (wo-component activator found in the Prime & Bond® NT™ adhesive system. When the selfand the same actrator roans in me on with the self-cure activator, it forms an adhesive layer that bonds to self-curing cements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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DENTSPLY International NAME & ADDRESS: World Headquarters Susquehanna Commerce Ctr. 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) (717) 849-4343 (fax) www.dentsply.com
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | May 26, 2005 |
| TRADE OR PROPRIETARY NAME: | XENO® ADHESIVE WITH ACTIVATOR |
| CLASSIFICATION NAME: | Resin tooth bonding agent, 872.3200 |
| PREDICATE DEVICES: | 1) XENO® NM Light Cured Dental Adhesive, K041343 |
- Prime & Bond® NT™ Dual Cure Nano-Technology
Universal Dental Adhesive System, K050386 |
DEVICE DESCRIPTION: XENO® ADHESIVE WITH ACTIVATOR is a dual-cure, self-etch, two-component adhesive system. It utilizes the same XENO® adhesive found in the predicate (wo-component activator found in the Prime & Bond® NT™ adhesive system. When the selfand the same actrator roans in me on with the self-cure activator, it forms an adhesive layer that bonds to self-curing cements.
INTENDED USE: XENO® ADHESIVE WITH ACTIVATOR is indicated for direct, light-INTENDED 0012: 11111100mer restorations; indirect restorations; light-cured resin cemented curcu composite, ceramic, and amalgam repairs; cavity varnish for use with fresh amalgam; vences, componer, ceramic, and masite restorations and core build-ups; resin cemented inlays, uncer, dual care of bell vetainers, and endodontic post cementation; and adhesive bonding of direct amalgam restorations.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in XENO® I ECHINOLOGICHE "ON "OR have been used in legally marketed devices and were found Safe for dental use. We believe that the prior use of the self-etching adhesive and the self-cure activator in legally marketed devices, the performance data provided, and the biocompatibility. data provided support the safety and effectiveness of XENO® ADHESIVE WITH ACTIVATOR for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." is arranged in a circle around the eagle.
JUL 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K051463
Trade/Device Name: XENO® Adhesive with Activator Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 26, 2005 Received: June 03, 2005
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & neverleview your cocken on (c) }
referenced above and have determined the device is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the encreated of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic mare been fortdornes and 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 connolis provisions or allabeling, 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 may of subject to been about Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Helen Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dry 3 issumite of a vacendinate squirements of the Act or that FDA has made a decemination and regulations and agencies. You must comply with CDS (2017) all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); an the Act s requirements, morading, but noving practice requirements as set forth in the quality iabeling (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) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally 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), please If you desire specific acreoliance at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Comphanes and (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general intolmation on your cosponsionmer 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,
Quy Suleom be
Clive E. Liu, Ph.D.
Chiu S. Lin. Ph Director 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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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
Kc 51463
510(K) Number (if known):
XENO® ADHESIVE WITH ACTIVATOR Device Name:
Indications for Use:
XENO® ADHESIVE WITH ACTIVATOR is indicated for:
- direct, light-cured composite and compomer restorations; .
- indirect restorations; .
- light-cured resin cemented veneers; .
- composite, ceramic, and amalgam repairs; .
- cavity varnish for use with fresh amalgam; .
- Cavity varmsil for asself-cure composite restorations and core build-ups; .
- unfect, dual-cure of sen care compoon and bridge retainers, and endodontic post . cementation; and .
- adhesive bonding of direct amalgam restorations. .
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.Betz DNS for Dr. S. Kunner
esthesiology, General Hospital.
510(k) Number: K031463
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