(40 days)
Not Found
No
The device description and intended use clearly describe a traditional dental material (glass ionomer liner/base) with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The basis for substantial equivalence is solely on design and technical specifications, further indicating a non-AI/ML device.
No.
The device is a liner/base material for dental restorations, not a therapeutic device designed to treat or prevent a disease.
No
The device is described as a "light-cure, glass ionomer liner/base material" used for "lining and basing applications under composite, amalgam ceramic and metal restorations." This indicates it is a restorative dental material, not a device used to diagnose a medical condition.
No
The device description clearly states it is a light-cure, glass ionomer liner/base material supplied as a powder and liquid, indicating it is a physical material, 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 "lining and basing applications under composite, amalgam ceramic and metal restorations." This describes a material used within the body during a dental procedure, not a test performed outside the body on a sample (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a "light-cure, glass ionomer liner/base material" composed of a powder and liquid. This is consistent with a dental restorative material, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
Therefore, Ionosit Bood is a dental material used in restorative procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ionosit Bood is indicated for use in lining and basing applications under composite, amalgam ceramic and metal restorations.
Product codes
Not Found
Device Description
Ionosit Bourd is a light-cure, glass ionomer liner/base material which is supplied in the form of a powder and liquid that are mixed prior to use. The liquid component contains a light sensitive polymerizable acid; the powder contains a fluoride-releasing special reactive glass.
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
Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Ionosit Bond
MAY 17
510(k) Summary
| Trade Name: | Ionosit Bond |
|---|---|
| Sponsor: | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Elbgaustrasse 248 | |
| 22547 Hamburg, Germany | |
| Registration No. 8010567 | |
| Device Generic Name: | Dental cement |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act the device classification is Class II |
Predicate Device:
The proposed DMG Ionosit Bond material is substantially equivalent to the Vitrebond material mirketed by 3M Dental Products, which was cleared for marketing by FDA in K962065 and K882821.
Product Description:
Ionosit Bourd is a light-cure, glass ionomer liner/base material which is supplied in the form of a powder and liquid that are mixed prior to use. The liquid component contains a light sensitive polymerizable acid; the powder contains a fluoride-releasing special reactive glass.
Indications for Use:
Ionosit Bood is indicated for use in lining and basing applications under composite, amalgam ceramic and metal restorations.
Safety and Performance:
Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Ionosit Bond material are equivalent to those of the predicate device. The proposed Ionosit Bond material conplies with FDA's Guidance for Dental Cements as well as ISO 9917-Part 2 (dental water-based cements).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate device, the Ionosit Bond material has been shown to be safe and effective for its intended use.
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| (5) Technological characteristic of the gloves. | |||||
|---|---|---|---|---|---|
| a. Dimensions | |||||
| Sizes | XS | S | M | L | XL |
| Length | 240 mm | 240 mm | 240 mm | 240 mm | 240 mm |
| Width | 80 111mm | ||||
| Thickness | |||||
| 1. Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| b. Physical Properties | |||||
| Before aging | After aging at 70°C 168 hrs. | ||||
| Tensile Strength | 21 Mpa | 16 Mpa | |||
| Ultimate Elongation | 700 % (min.) | 600 % (min.) |
(6) Performance data is the same as mentioned immediately above.
(7) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (8) Non-clinical data We certify that these gloves meet ASTM D 3578 Standard. Meets FDA pinhole requirement. Meets labeling claim.