(33 days)
Not Found
Not Found
No
The summary describes a dental adhesive and does not mention any AI or ML components or functionalities.
No.
The device is an adhesive used for bonding dental restorations, which is not considered a therapeutic function.
No
This device is an adhesive used for bonding restorations, not for diagnosing medical conditions. The description focuses on its chemical composition and application in dental procedures, not on identifying diseases or conditions.
No
The device description clearly indicates it is a chemical adhesive product, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a product used for bonding dental restorations directly to the tooth structure. This is a clinical application performed on a living patient.
- Device Description: The description reinforces its use as a dental adhesive for bonding procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are used to perform tests outside of the body on biological samples to gain information about a patient's health status. This device is used inside the body to facilitate dental procedures.
N/A
Intended Use / Indications for Use
The intended use of Optibond All-In-One is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, light-cured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain, composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.
OptiBond All-In-One is a self-etching adhesive which combines the ingredients needed for etching, priming, and bonding into a single adhesive solution and is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, lightcured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain. composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
OptiBond All-In-One self-etching adhesive combines the ingredients needed for etching, priming, and bonding into a single adhesive solution, thereby eliminating separate etching and priming steps of the bonding process. OptiBond All-In-One adhesive can be used for the bonding of both direct and indirect restorations. The advantages of using OptiBond All-In-One adhesive include simplified bonding procedures and reduced post-operative sensitivity. OptiBond All-In-One incorporates the proven GPDM adhesive technology used in Optibond Solo Plus, fillers that contain fluoride and nano-fillers. This unique technology ensures the highest level of protection against microleakage while providing high bond strengths to a variety of substrates.
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.
Not Found
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
MAR 2 8 2006 SYBRON DENTAL SPECIALTIES Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: February 2006
Device Name:
- Trade Name Optibond All-In-One .
- . Common Name - Resin Tooth Bonding Agent
- Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .
Devices for Which Substantial Equivalence is Claimed:
- GC America, Inc., G-Bond .
Device Description:
OptiBond All-In-One self-etching adhesive combines the ingredients needed for etching, priming, and bonding into a single adhesive solution, thereby eliminating separate etching and priming steps of the bonding process. OptiBond All-In-One adhesive can be used for the bonding of both direct and indirect restorations. The advantages of using OptiBond All-In-One adhesive include simplified bonding procedures and reduced post-operative sensitivity. OptiBond All-In-One incorporates the proven GPDM adhesive technology used in Optibond Solo Plus, fillers that contain fluoride and nano-fillers. This unique technology ensures the highest level of protection against microleakage while providing high bond strengths to a variety of substrates.
Intended Use of the Device:
The intended use of Optibond All-In-One is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, light-cured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain, composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.
Substantial Equivalence:
Optibond All-In-One is substantially equivalent to other legally marketed devices in the United States. The self-etching adhesive marketed by GC America, Inc. functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660
Re: K060469
Trade/Device Name: Optibond All-In-One Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 22, 2006 Received: February 23, 2006
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.
2
Page 2 - Ms. Colleen Boswell
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 Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
C. L. Rice, 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
Section I
Indications for Use
510(k) Number (if known): | 6660469
Device Name: OptiBond All-In-One
Indications For Use:
OptiBond All-In-One is a self-etching adhesive which combines the ingredients needed for etching, priming, and bonding into a single adhesive solution and is used for direct situations, i.e., light-cured composite and compomer restorations,
composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, lightcured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain. composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.
Prescription Use 1 (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)
logy, General Hospi
ontrol, Dental Devices
Page 1 of