(78 days)
Not Found
Not Found
No
The 510(k) summary describes a dental bonding agent and primer, focusing on chemical composition and application process, with no mention of AI or ML.
No
This device is a self-etch primer used for bonding dental restorations, which is a structural or restorative function rather than a therapeutic one (treating a disease or condition). Its intended use is to prepare the tooth surface for bonding, not to heal or cure.
No
The device is a self-etch primer used for bonding dental restorations, which is a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly identifies the product as a "self-etch primer," which is a chemical substance used in dentistry, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dental material used for bonding and repairing teeth and dental restorations. This is a direct application to the body (or a material being applied to the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a self-etch primer used in conjunction with a tooth bonding agent for dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).
Product codes
KLE
Device Description
OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive (in Unidose or bottle delivery), both a Class II device which were granted marketing clearance by FDA following the submission of a 510(k) premarket notification. When used with OptiBond Solo Plus or OptiBond Solo Plus with Activator, the self-etch primer can be used in the bonding of both direct and indirect restorations. The self-etch primer is used to eliminate the phosphoric acid etch step in the bonding process. Some advantages of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth, enamel, 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
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Key Metrics
Not Found
Predicate Device(s)
Kuraray America, Inc., Clearfil Liner Bond 2V
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
KO McQrz
Image /page/0/Picture/1 description: The image shows a logo with the letters 'sds' in a stylized, interconnected design. A curved line extends from the left, arcing over the letters to add a dynamic element. Below the letters, partial text is visible, suggesting the words 'DENTAL SPECIALIST' are present, though the beginning of the phrase is cut off.
BRON DENTAL SPECIALTIES
FEB 2 2 2002
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
December 2001
Date Summary Prepared:
Device Name:
- 11
- Trade Name -- Optibond Solo Plus 4 .
- Common Name Resin Tooth Bonding Agent •
- Common Name -- Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .
Devices for Which Substantial Equivalence is Claimed:
Kuraray America, Inc., Clearfil Liner Bond 2V .
Device Description:
OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive of OptiBond Solo Plus 4 seti-etch primer is designior (in Unidose or bottle delivery), both a Class II
OptiBond Solo Plus adhesive with dual cure activator (in cubmission of a 5 OptiBond Solo Flus addiesIve will dadi care access by FDA following the submission of a 510(k)
device which were granted marketing clearance by Flaxed Solo Rus with Acity device which were grained marketing trearance of the or OptiBond Solo Plus will Activator,
premarket notification. When used with OptiBond Solo Plus or restorations. The self premarket notification. When used in the bonding of both direct restorations. The self-etch the self etch primer can be used in the bonumy of the bonding process. Some advantages
primer is used to eliminate the phosphoric acid etch separitive and an elimination of primer is used to enminate the phospilore actires and other of i
of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.
Intended Use of the Device:
The intended use of Optibond Solo Plus 4 can be used for direct situations, i.e., composite to enamel The intended tise of Optional Solo I rus 4 can or assess to metal, annalgam sealing, post and bridges and/or dentin, composite repart, porcelan ropan, composite of theys, crowns and bridges
core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crown (used in conjunction with a resin luting agent).
Substantial Equivalence:
Optibond Solo Plus 4 is substantially equivalent to other legally marketed devices in the United Optibond Solo Plus 4 is substantially equivalent volter regal, Inc. finctions in a maners similar to
States. The self-etching primer marketed by Kurray Marchal Materials Cen States. The self-etching primer marketed by Kultiray Princitus, and
800-537-7824 714-516-7400 1717 West Collins Avenue, Orange, CA 92800
1
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the Department of Health & Human Services, which is an abstract image of an eagle. The text around the seal reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Ms. Colleen Boswell Kerr Dental Materials Center Center A Division of Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K014027
Trade/Device Name: Optibond Solo Plus 4 Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 4, 2001 Received: December 6, 2001
Dear Ms. Boswell:
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 approvisions of the Act. The general controls provisions of the Act include contrements 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 (1 will), it ind) 00 basyon 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 - Ms. Boswell
You must comply with all the Act's requirements, including, but not limited to: registration I ou must compry with an are reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pac 007), lacems (QS) regulation (21 CFR Part 820); and if requirences as set forth in als quality sion 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 mis letter will anow you to ocelli manage you of substantial equivalence of your device to 310(K) promation nownloate 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 II you desire specific ac not 10-10-10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Othoo of Collightance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nothication (21CF ICPart For 001997).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may be counter 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,
Timothy A. Ulatowski
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
Section I
Indications for Use Statement
Ver/3-4/24/96
Applicant: Kerr Dental Material Center
| Labels | Values |
|---|---|
| 510(k) Number (if known): | 2014027 |
Device Name: Optibond Solo Plus 4
Indications For Use:
Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).
Susan Runs
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices,
| Labels | Values |
|---|---|
| 510(k) Number | K014007 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)