(80 days)
No
The summary describes a chemical bonding system and does not mention any AI or ML components or functionalities.
No
The device is a bonding system used to attach composite materials to teeth, which is a restorative rather than therapeutic function.
No
The device is a bonding system intended to bond composite materials to tooth structure, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "3-component resin tooth bonding system" composed of an etching gel, primer, and bonding agent, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intended to bond composite materials to the tooth structure." This describes a direct interaction with the patient's body (the tooth) for a therapeutic or restorative purpose.
- Device Description: The description details a "3-component resin tooth bonding system" used for bonding materials to the tooth structure. This is consistent with a dental restorative or adhesive device.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) to perform a dental procedure.
N/A
Intended Use / Indications for Use
The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.
Product codes
Not Found
Device Description
The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent. The etching gel used in the EBS® System is ESPE's 510(k) cleared MiniTip Etching Gel (K810266), and the bonding agent used in the EBS® product is ESPE's 510(k) cleared Pertac® Universal Bond (K904289), tradenamed EBS® Bond. The primer used in the EBS® product, tradenamed EBS® Primer, is substantially equivalent to the primer in 3M's Scotchbond™ Multi-Purpose Dental Adhesive System (K920424).
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
To support substantial equivalence to 3M's predicate product, the shear bond strength of the EBS® System has been compared to that of the Scotchbond™ System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
SEP 12 1988 K962428
II. 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for its 3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent. The etching gel used in the EBS® System is ESPE's 510(k) cleared MiniTip Etching Gel (K810266), and the bonding agent used in the EBS® product is ESPE's 510(k) cleared Pertac® Universal Bond (K904289), tradenamed EBS® Bond. The primer used in the EBS® product, tradenamed EBS® Primer, is substantially equivalent to the primer in 3M's Scotchbond™ Multi-Purpose Dental Adhesive System (K920424). Both products have identical ingredient compositions and the same intended uses.
To support substantial equivalence to 3M's predicate product, the shear bond strength of the EBS® System has been compared to that of the Scotchbond™ System.
ESPE's 510(k) has been submitted on June 24, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
WA01A/A48418.1
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