(87 days)
No
The summary describes a dental luting composite system and its physical and mechanical properties, with no mention of AI or ML.
No
The device is a luting composite system for the permanent cementation of indirect dental restorations, which is a restorative rather than therapeutic function.
No
Explanation: The device is described as a luting composite for permanent cementation of dental restorations, performing a therapeutic function (bonding) rather than diagnosing a condition.
No
The device description clearly indicates it is a "self-curing and self-etching luting composite system," which is a physical material (a composite) used for dental procedures, 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 for the permanent cementation of indirect dental restorations. This is a dental procedure, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is a luting composite system used to bond dental materials. This aligns with its use in dental procedures, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the dental material (strength, solubility, etc.) and biocompatibility, which are relevant to its use as a dental cement, not a diagnostic device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired:
- Inlays, onlays, crowns, bridges and root posts made of: –
- o Metal and metal ceramics
- o All-ceramics, in particular opaque zirconium oxide ceramics
- o Composites and fibre-reinforced composites
Product codes
EBF
Device Description
Multilink Automix is a self-curing and self-etching luting composite system for the adhesive luting of indirect restorations made of metalceramic all-ceramic and composite. Multilink Automix is applied together with the selfetching and self-Ocuring Multilink Primer. Monobond Plus is recommended as a coupling agent to achieve a strong bond to precious and non-precious alloys, as well as to all ceramics made of zirconium and aluminum oxide and silicate ceramics.
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
The device was tested in accordance with ISO 4049:2000 for Polymer based dental restorative materials for Water Absorption, Water solubility, radiopacity, Flexural Strength, Modulus of Elasticity, Compressive Strength and Shear Bond Strength and the results from testing demonstrates that Multilink Automix is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.
Key Metrics
| Property | UOM | Multilink (K032470) | Multilink Automix Self Curing | Multilink Automix Dual Curing |
|---|---|---|---|---|
| Working time (37C) | Min | 3-4 | 3-4 | -- |
| Setting time | Min | 7-9 | 6-7 | -- |
| Film Thickness | µm |
§ 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
MULTILINK AUTOMIX
JAN 3 1 2013
K | 23397
Donna Marie Hartnett Contact:
Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228 Company: (716) 691-0010
December 4, 2012 Date Prepared:
Multilink Automix Proprietary Name:
Material, Tooth Shade, Resin (872.3690) Classification Name:
Predicate Devices: Multilink (K032470)
Multilink Automix is a self-curing and self-etching luting Device Description: composite system for the adhesive luting of indirect restorations made of metalceramic all-ceramic and composite. Multilink Automix is applied together with the selfetching and self-Ocuring Multilink Primer. Monobond Plus is recommended as a coupling agent to achieve a strong bond to precious and non-precious alloys, as well as to all ceramics made of zirconium and aluminum oxide and silicate ceramics.
The predicate device to which Multilink Automix has been compared is Multilink (K032470). For this application. Multilink Automix has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Multilink Automix is substantially equivalent to the predicate device.
Intended Use:
Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired:
- Inlays, onlays, crowns, bridges and root posts made of: –
- o Metal and metal ceramics
- o All-ceramics, in particular opaque zirconium oxide ceramics
- o Composites and fibre-reinforced composites
Technological Characteristics: The device design, i.e. delivery form, and intended use of Multilink Automix and the predicate device are the same. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.
Testing Summary: The device was tested in accordance with ISO 4049:2000 for Polymer based dental restorative materials for Water Absorption, Water solubility, radiopacity, Flexural Strength, Modulus of Elasticity, Compressive Strength and Shear Bond Strength and the results from testing demonstrates that Multilink Automix is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.
510K Summary 5-1
1
510(K) SUMMARY MULTILINK AUTOMIX
The following table shows the performance data of Multilink Automix and its predicate device: . .
・
.
.
| Property | UOM | Multilink
(K032470) | Multilink Automix | Multilink Automix |
|--------------------------------------------------------------------------|--------|---------------------------|---------------------------|---------------------------|
| | | | Self Curing | Dual Curing |
| Working time (37C) | Min | 3-4 | 3-4 | -- |
| Setting time | Min | 7-9 | 6-7 | -- |
| Film Thickness | μm |