(78 days)
Not Found
No
The summary describes a dental bonding agent and does not mention any AI or ML capabilities.
No
The device is a bonding agent used in dental restorations, which is a structural and cosmetic treatment, not a therapeutic intervention for disease or medical conditions.
No
Explanation: The device, Prelude, is described as a light-cured adhesive and dental bonding agent used for restorations (composites, compomers, veneers, crowns, etc.). Its function is to bond materials, not to diagnose a condition or disease.
No
The device description clearly states it is a "dental bonding agent," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a dental adhesive used for bonding restorative materials to teeth. This is a direct application within the body (or on a part of the body, the tooth), not a test performed on a sample taken from the body.
- Device Description: The description confirms it's a dental bonding agent used to restore cavities, reinforcing its direct application in dentistry.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
"Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials."
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
"Prelude is a dental bonding agent used to restore all classes of cavities."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and/or dentin (related to dental restorations)
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.
K990498, K014027, K990040, K012082
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
K040952
JUN 2 9 2004
510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)
| Applicant: | Danville Materials, Inc.
2021 Omega Dr.
San Ramon, CA 94583 |
|----------------------|----------------------------------------------------------------------------|
| Contact Person: | Craig R. Bruns |
| | Phone 925 838-7940 |
| | Fax 925 838-0944 |
| e-mail: | cbruns@daneng.com |
| Date of summary | March 12, 2004 |
| Device name | Prelude |
| Common name | Agent, Tooth Bonding, Resin |
| Classification names | Regulation Number
21 CFR 872.3200
Product Code
KLE |
| Device Description | Prelude is a dental bonding agent used to restore all classes of cavities. |
Predicate Device The device is substantially equivalent to other legally marketed devices in the United States including Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040) and Optibond Solo Plus Activator (K012082).
Intended Use Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow downwards.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2004
Mr. Craig R. Bruns President Danville Materials, Inc. 2021 Omega Road San Ramon, California 94583-1229
Re: K040952
Trade/Device Name: Prelude Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 23, 2004 Received: June 24, 2004
Dear Mr. Bruns:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your over of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the encreated to the Medical Device Amendments, or to devices that prov to way 20, 1970, and cordance 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 thereone, mancer me act include requirements for annual registration, listing of devices, good connologic provisions or abeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device to such additional controls. Existing major regulations affecting your device can be finay of subject to sten adam 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. Craig R. Bruns
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession in other requirements of the Act of that FDA nas made a delectimization that your cell be other Federal agencies. You must comply with CEP Bett 807V any Federal statures and regulations administered of to: registration and listing (21 CFR Part 807); all the Act s requirements, including, but not interest see requirements as set forth in the quality labeling (21 CFR 1 art 001), good management of applicable, the electronic product radiation systems (QB) rogalazen ons 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 his letter whi anow you to ought manteeing your and equivalence of your device to a legally premarket notification. The PDA midning of bassification 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 ativice for your actives at (301) 594-4613. Additionally, for questions on the promotion comact the Office of Compliance at (301) 591-1698 contact the Office of Compliance at (301) 594-4639 (2) OFF and advertising of your device, prease verrance to premarket notification" (21CFF)
please note the regulation entitled, "Misbranding by reference to premarket notification th please note the regulation entities, "Information on your responsibilities under the Act may Patt 807.97) you they obtain. Other generaliantacturers, 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/dsma/dsmamain.html
Sincerely yours,
Clive S. Lewis, Ph.D.
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
Indications for Use
K040452 510(k) Number (if known): Pending
Device Name: Prelude
Indications For Use:
Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or I reado is a right direct can repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude may also be used with self or dual cure materials.
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)
Suar Rann
Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K041015