(71 days)
No
The summary describes a chemical/material-based system for dental restoration and cementation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a 4-component system for intraoral adhesive repair and pretreatment for adhesive cementation, which are restorative and preparative dental procedures, not therapeutic in nature.
No
The device is described as a system for intraoral adhesive repair and pretreatment for adhesive cementation, not for identifying or diagnosing medical conditions.
No
The device description clearly lists physical components (sand, silane coupling agent, bonding material, opaquer) which are not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed intraorally (within the mouth) for repairing and cementing dental restorations. This is a direct treatment or preparation for treatment on a patient.
- Device Description: The components are materials used in dental procedures (sand, silane, bonding material, opaquer). These are applied directly to the patient's teeth or restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CoJet™-System's function is entirely focused on the physical repair and preparation of dental structures within the mouth.
N/A
Intended Use / Indications for Use
The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include:
- adhesive repair of defects in porcelain
- adhesive repair of defects in porcelain with exposed metal -
- adhesive repair of defects in composite -
- adhesive repair of defects in composite with exposed metal
- conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
- conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.
Product codes
Not Found
Device Description
ESPE is submitting a 510(k) premarket notification for its 4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
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)
Performance data demonstrate that the products' performance is not affected by intraoral preparation and use.
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.
K913857, K902836/A, K913965, K790833/B, K833757
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.
K925027, K960547, K900510, K913966, K911061
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 2 7 1996
ESPE is submitting a 510(k) premarket notification for its 4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include:
- adhesive repair of defects in porcelain
- adhesive repair of defects in porcelain with exposed metal -
- adhesive repair of defects in composite -
- adhesive repair of defects in composite with exposed metal
- conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
- conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.
The CoJet™-Sand used in the CoJet™-System is ESPE's 510(k)-cleared Rocatec®-Plus (K913857), except for the addition of a pigment, iron oxide (C.I. 77491), and the use of more finely grained sand (30 um versus 110 um). The iron oxide pigment is a medical device-listed color additive at 21 C.F.R. § 73.3125, and has been used in the following ESPE 510(k)-cleared products: Photac®-Fil Aplicap® (K925027), Dimension materials (K960547), Pertac®-Hybrid (K900510), Sono-Cem (K913966), and Ketac-Endo Aplicap® (K911061). CoJet™-Sand also is
WA01A/65040.1
- 2 -
1
substantially equivalent to the aluminum oxide material used in the Microetcher™ Dental Bonding System (K902836/A). The silane coupling agent in the System is ESPE's 510(k)cleared ESPE®-SIL (K913965), and the bonding material is ESPE's 510(k)-cleared Visio®8-Bond (K790833/B). Finally, the Opaquer is a component of Visio®-Gem, ESPE's 510(k)cleared crown and bridge veneer material for light polymerization (K833757). The only modification to these previously cleared ESPE components is that they will be prepared and used intraorally, rather than prepared extraorally, for subsequent intraoral use. One of the predicates for CoJet™-Sand, Microetcher™, however, has been cleared for intraoral preparation and use. Performance data demonstrate that the products' performance is not affected by intraoral preparation and use.
ESPE's 510(k) has been submitted on September 17, 1995 by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).