(16 days)
Not Found
No
The device description and intended use clearly describe a dental adhesive system, and there is no mention of AI, ML, or any related technologies.
No.
The device is a dental adhesive system used for bonding materials in dental restorations, not for treating diseases or conditions.
No
The device description and intended use indicate that XP BOND is a dental adhesive system used for bonding various restorative materials. It does not perform any diagnostic function.
No
The device description clearly states it is a "dental adhesive system," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on a patient's teeth (enamel and dentin) for restorative purposes. This is a clinical application, not an in vitro diagnostic test.
- Device Description: The description clearly states it's a "dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic." This is consistent with a dental material used in a clinical setting.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are used to perform tests outside of the body.
Therefore, XP BOND is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
XP BOND is indicated for
-
- Direct, Light-cured composite and compomer restorative.
-
- Indirect Restorations; Light-cured, resin cemented Veneers.
-
- Composite, ceramic and amalgam repairs.
-
- Cavity varnish for use with fresh amalgam.
-
- Direct, dual cure or self-cure composite restorations and core build-ups.
-
- Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers.
-
- Dual cured and self cured resin cemented Endodontic post cementation.
-
- Adhesive bonding of direct amalgam restoration.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
The XP BOND Dual Cure is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL ADHESIVE, K050386
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SECTION 5: 510(k) SUMMARY
MAR 1 4 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | February 23, 2007 |
| TRADE OR PROPRIETARY NAME: | XP BOND Dual Cure Universal Total Etch |
| Adhesive | |
| CLASSIFICATION NAME: | Agent, Tooth Bonding, Resin |
| REGULATION NUMBER: | 21CFR872.3200 |
| PRODUCT CODE: | KLE |
| PREDICATE DEVICES: | PRIME & BOND NT DUAL CURE NANO- |
| TECHNOLOGY UNIVERSAL ADHESIVE, K050386 |
DEVICE DESCRIPTION: The XP BOND Dual Cure is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic.
INTENDED USE: XP BOND is indicated for
CONTACT:
- 1 . Direct, Light-cured composite and compomer restorative.
-
- Indirect Restorations; Light-cured, resin cemented Veneers.
-
- Composite, ceramic and amalgam repairs.
-
- Cavity varnish for use with fresh amalgam.
- న్. Direct, dual cure or self-cure composite restorations and core build-ups.
- Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and 6. bridge retainers.
- Dual cured and self cured resin cemented Endodontic post cementation. 7.
-
- Adhesive bonding of direct amalgam restoration.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in XP BOND have been used in legally marketed devices and were found safe for dental use. XPBOND has been evaluated and passed biocompatibility testing for Cytotoxicity, Ames Test.
We believe that the prior use of the components of XP BOND in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of XP BOND for the indicated uses.
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design. The eagle is a common symbol of the United States, and its presence in the logo reinforces the department's connection to the U.S. government.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2007
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: K070538
Trade/Device Name: XP BOND Dual Cure Universal Total Etch Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 23, 2007 Received: February 26, 2007
Dear Ms. Lewis:
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 - Ms. Helen Lewis
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" (21 CFR 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/cdrb/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4: INDICATIONS FOR USE
1070538
510(k) Number (if known):
Device Name: XP BOND Dual Cure Universal Total Etch Adhesive
Indications for Use:
XP BOND is indicated for
-
- Direct, Light-cured composite and compomer restorative.
- Indirect Restorations; Light-cured, resin cemented Veneers. 2.
-
- Composite, ceramic and amalgam repairs.
-
- Cavity varnish for use with fresh amalgam.
-
- Direct, dual cure or self-cure composite restorations and core build-ups.
- Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and 6. bridge retainers.
- Dual cured and self cured resin cemented Endodontic post cementation. 7.
-
- Adhesive bonding of direct amalgam restoration.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Susan Runno
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