(71 days)
Not Found
No
The summary describes a chemical bonding agent and an activator, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a dental bonding agent, used for adhesion of dental restorations, not for treating a disease or condition.
No
The device is a bonding agent used to adhere restorations to tooth structures, which is a therapeutic rather than a diagnostic function.
No
The device is a dental bonding agent and activator, which are chemical substances, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding dental materials (dentin/enamel, amalgam restorations) to tooth structures. This is a direct application within the body for therapeutic or restorative purposes.
- Device Description: The description details a dental bonding agent and an activator that initiates polymerization for adhesion. This is a material used in a dental procedure.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the mouth for a restorative dental procedure.
N/A
Intended Use / Indications for Use
Also because of the self-cure capability, use of the Bonding Agent and Activator cogether allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE.
Product codes
21 CFR, 872.3200
Device Description
Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process.
A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond" 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired.
& Bond™ Self-Curing Activator is an acetone/ethanol solution of an aromatic sulfinic acid salt. When applied in combination with Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent, the Activator initiates a self-cure, free radical polymerization of the monomers and oligomers present in the Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent.
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
JAN 22 1997
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS :
849-6363 P. J. Lehn Telefax
P. Jeffery Lehn CONTACT :
November 11. 1996 DATE PREPARED:
PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT TRADE NAME: WITH ACTIVATOR
Bonding agent COMMON OR USUAL NAME:
21 CFR, 872.3200 Resin tooth bonding agent CLASSIFICATION NAME:
PREDICATE DEVICES: Scotchbond M.P. Plus Dental Adhesive System K942493 K962348 Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent
Prime & Bond™ 2.1 Multipurpose Dentin/Enamel DESCRIPTION AND INTENDED USE: Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process.
A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond" 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired.
Also because of the self-cure capability, use of the Bonding Agent and Activator cogether allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE.
& Bond™ Self-Curing Activator is an acetone/ethanol solution of an Prime aromatic sulfinic acid salt. When applied in combination with Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent, the Activator initiates a self-cure, free radical polymerization of the monomers and oligomers present in the Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent.
1
510(k) SUMMARY (cont'd.)
TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT WITH ACTIVATOR
TECHNOLOGICAL CHARACTERISTICS: No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process.
All of the components of the Prime & Bond® Self-Curing Activator have been used in legally marketed devices or have been proven to be safe for dental use.
We believe the fact that Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent has not been changed, the prior use of the Prime & Bond™ Self-Guring Activator components in predicate devices, the performance data presented for the use of Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent with the Prime & Bond Self-Curing Activator, and the cytotoxicity test results of the Activator active ingredient support the safety and effectiveness of Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent when used with Prime & Bond® Self-Curing Activator for the new indications for use.