(79 days)
Not Found
No
The document describes a chemical bonding agent and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is a bonding agent used for dental materials, not for treating diseases or conditions. It acts as an adhesive in dental procedures.
No
The device is described as a multi-purpose bonding agent for materials used in dentistry, not for diagnosing conditions.
No
The device description clearly states it is a "multi-purpose bonding agent," which is a chemical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for bonding dental materials (core materials, resin cements, posts, amalgams) to teeth. This is a direct application within the body (or on a part of the body), not for testing samples taken from the body.
- Device Description: The description reinforces its use as a bonding agent in conjunction with another dental device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for physical bonding within a dental procedure.
N/A
Intended Use / Indications for Use
OptiBond Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with Optitloud Solo Phus, a Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and comentation of posts and amalgams.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
OptiBoud Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with Optitloud Solo Phus, a Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and comentation of posts and amalgams.
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.
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
SEP 2 0 2001
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.
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 Collecn Boswell - Contact Person
Date Summary Prepared: June 2001
Device Name:
- Trade Name -- OptiBond Solo Plus Activator ﻮ
- Common Name -- Resin Tooth Bonding Agent *
-
- Classification Name - Resin Tooth Bonding Agent, per 21 CFR § 872.3200
Devices for Which Substantial Equivalence is Claimed:
Dentsply Canlk, Prime & Bond NT Dual Cure .
Device Description:
OptiBoud Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with Optitloud Solo Phus, a Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and comentation of posts and amalgams.
Intended Use of the Device:
The intended use of OptiBond Solo Plus Activator is for bonding of core materials, resin coments, and cementation of posts and amalgams.
Substantial Equivalence:
OptiBond Solo Plus Activator is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Dentsply Caulk functions in a manner sincilar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
1
Section IV -- Substantial Equivalence
The table on the following page compares the bonding property of OptiBond Solo Plus Activator to one other legally marketed, Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. The 510(k) number for the predicate device, Prime & Bond NT Dual Cure, is K982394 dated September 21,1998.
Representative labeling for the device to which equivalonce is being claimed is also included on the following pages. OptiBond Solo Plus Activator functions in a manner similar to and is intended for the same use as Prime & Bond NT Dual Cure marketed by Dentsply Caulk. Additionally, the product specifications for OptiBond Solo Plus Activator are also provided in this section.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
SEP 2 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K012082
Trade/Device Name: Optibond Solo Plus Activator Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 29, 2001 Received: July 3, 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 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.
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.
3
Page 2 - Ms. Boswell
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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours.
Timothy A. Uhlmann
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section I
Indications for Use Statement
Ver/3 - 4/24/96
Applicant: Kerr Dental Material Center
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K012082 |
Device Name: OptiBond Solo Plus Activator
Indications For Use:
OptiBond Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with a tooth bonding agent. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and cementation of posts and amalgams.
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| Labels | Values |
|---|---|
| 510(k) Number | K012082 |
(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)