(30 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a dental bonding agent, with no mention of AI or ML technologies.
No.
This device is a dental bonding agent used in restorative procedures, not a therapeutic device designed to treat or cure a disease or condition. Its purpose is to adhere restorative materials to the tooth.
No
Explanation: The device is a dental bonding agent used for restorative procedures and adhesive repairs; it does not identify or diagnose any medical conditions.
No
The device description clearly states it is a "one-component, no-mix, visible light curing dental bonding agent" consisting of a "mixture of monomers, fluoride, and an adhesion promoter in an acetone solution," which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a dental bonding agent applied directly to the tooth (an anatomical site). It is used in restorative procedures and repairs, not for analyzing samples taken from the body.
- Intended Use: The intended uses are related to dental procedures (bonding, repair, varnish), not diagnostic testing.
Therefore, this device falls under the category of a dental device used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PRIME & BOND™ 2,1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish. The intended uses of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT are identical to the intended uses of Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823).
Product codes
Not Found
Device Description
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix, visible light curing dental bonding agent that releases fluoride.
The new bonding agent consists of a mixture of monomers, fluoride, and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy.
Once the tooth to be restored has been prepared, PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures.
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT and Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) are comparable in direct composite bond strength (dentin, enamel, adhesive repair), indirect composite bond strength (metal appliances, inlays, veneers), and microleakage values. PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT has a high degree of marginal integrity and a reduced incidence of post operative hypersensitivity.
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)
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
K9623348
510(k) SUMMARY
Page 1 of 2
DENTSPLY
NAME & ADDRESS:
11 18 1996
DENTSPLY International 570 West College Avenue P O. Box 872 York, PA 17405-0872 7171 845-7511 -ax (717) 854-2343 (717) 849-4343 P. J. Lehn Telefax
P. Jeffery Lehn CONTACT :
June 17, 1996 DATE PREPARED:
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT TRADE NAME:
COMMON OR USUAL NAME: Bonding agent
21 CFR, 872.3200 CLASSIFICATION NAME: Resin tooth bonding agent
PREDICATE DEVICES :
| Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent | K960823 |
|---|---|
| Fluoride-PSA Prime/Adhesive | K941572 |
| Prime & Bond Direct Composite Bonding Agent | K931812 |
DEVICE DESCRIPTION: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix, visible light curing dental bonding agent that releases fluoride.
The new bonding agent consists of a mixture of monomers, fluoride, and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy.
Once the tooth to be restored has been prepared, PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures.
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT and Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) are comparable in direct composite bond strength (dentin, enamel, adhesive repair), indirect composite bond strength (metal appliances, inlays, veneers), and microleakage values. PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT has a high degree of marginal integrity and a reduced incidence of post operative hypersensitivity.
INTENDED USE: PRIME & BOND™ 2,1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish. The intended uses of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT are identical to the intended uses of Prime & Bond™ 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823).
1
510(k) SUMMARY (cont'd.)
TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
TECHNOLOGICAL CHARACTERISTICS: All of the components of PRIME & BOND™ 2.1 SELF-PRIMING DENTIN/ENAMEL BONDING AGENT have been used in the DENTSPLY predicate devices, Prime & Bond® 2.0 Multipurpose Dentin/Enamel Bonding Agent (K960823) and Fluoride-PSA Prime/Adhesive (K941572). These devices were evaluated for cytotoxicity and for irritation and found to be non-cytotoxic and a non-irritant. Due to the similarity of the new formulation to the primary predicate device (K960823), we believe that additional toxicity testing for PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is unnecessary.
We believe that the prior use of the PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT components in predicate devices, the near identical formulation to the predicate device, the performance data and fluoride release data presented, and the results of toxicity testing on predicate devices, support the safety and effectiveness of PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT for the intended uses.