(83 days)
No
The device description and performance studies focus on chemical properties and physical performance, with no mention of AI/ML or related concepts like image processing or data analysis using algorithms.
No
The device is described as "etching of the surface" of tooth material prior to restoration, which is a preparatory step for a dental procedure, not a treatment for a disease or condition itself.
No
The device's Intended Use is for "preparation of tooth material prior to restoration by etching of the surface," which is a preparative or treatment step, not a diagnostic one.
No
The device description clearly states it is a gel containing ortho-phosphoric acid, which is a physical substance, 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 "in preparation of tooth material prior to restoration by etching of the surface." This is a direct treatment or preparation of a biological material in situ (on the tooth), not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a gel containing phosphoric acid, used for etching. This is a chemical process applied directly to the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing.
IVDs are specifically designed to perform tests on samples taken from the body to gain information about the body's state. This device is used on the body to prepare a surface for a procedure.
N/A
Intended Use / Indications for Use
These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.
Product codes
Not Found
Device Description
These materials consist of a gel containing ortho-phosphoric acid.
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
Non-clinical testing includes tests for pH, acid content, adhesion and water washability. The tests indicate results for pH and acid content which are comparable within formulation and experimental accuracy. The test for adhesion indicates better adhesion of the subject device. The test for water washability indicates marginally easier washability for the predicate device. This is a direct result of the intentionally increased viscosity (and adhesion) of the subject device. The washability of the subject device is satisfactory on consideration of the method of removal.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
23 MAILE
SS White Manufacturing 9 Madleaze Estate, Bristol Road, Gloucester, GL1 5SG. England.
9 Madleaze Estate, Bristol Road, Gloucester, GL1 5SG. England. 9 Mauleaze Estato) 307171. Fax: (01452) 307187
PREMARKET NOTIFICATION
510(k) SUMMARY
- S.S. White Manufacturing NAME :
- Unit 9, Madleaze Estate, ADDRESS : Bristol Road, Gloucester, GLI England
- 01452 307171 PHONE No:
- 01452 307187 FAX No.:
- Hugh Savell CONTACT : SS White Group Compliance Manager
DATE PREPARED: 9th October, 1996
Image /page/0/Picture/10 description: The image shows three circular shapes in a row. The first circle has a complex pattern of black and white, with a large black shape in the center surrounded by white and black areas. The second circle is completely black. The third circle is mostly black with a small white spot in the center.
JAN. 9, 1997
1
Image /page/1/Picture/0 description: The image shows a word that is difficult to read due to its stylized and somewhat distorted appearance. The word appears to be written in a bold, sans-serif font, with thick strokes that make it challenging to distinguish individual letters. The overall impression is that of a logo or a stylized wordmark, where readability is sacrificed for visual impact.
PREMARKET NOTIFICATION
510(k) SUMARY (continued)
Super-Dent Etching Gel TRADE NAMES: Super-Dent Micro-Etch Gel Super-Dent Etching Gel Syringe Tips
Phosphoric acid etching gel COMMON NAME:
Dental cement accessory, phosphoric CLASSIFICATION NAME: acid etching gel
Zenith 40% Phosphoric Acid Gel EQUIVALENT TO: 510(k) No. K890464
DESCRIPTION :
These materials consist of a gel containing ortho-phosphoric acid.
INTENDED USE:
These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.
TECHNOLOGICAL CHARACTERISTICS:
Both devices are aqueous gels containing a nominal 40% orthophosphoric acid and delivered directly to the restoration site from a syringe via a hollow applicator. Both devices are coloured for visibility in contrast with tooth material. They are sufficiently viscous to remain where placed and avoid potentially harmful contamination of more sensitive oral tissues. Both devices wash readily from the site when etching is complete.
The subject device is intentionally more viscous than the predicate device to improve adhesion after placement.
2
Image /page/2/Picture/0 description: The image shows a heavily distorted and obscured text string. Due to the extreme distortion and heavy black fill, individual characters are difficult to discern with certainty. The overall impression is that of a word or phrase that has been intentionally obscured or damaged.
PREMARKET NOTIFICATION
510(k) SUMMARY (continued)
NON-CLINICAL DATA:
Non-clinical testing includes tests for pH, acid content, adhesion and water washability.
The tests indicate results for pH and acid content which are comparable within formulation and experimental accuracy.
The test for adhesion indicates better adhesion of the subject device. The device is intentionally more viscous than the predicate device to improve adhesion after placement.
The test for water washability indicates marginally easier washability for the predicate device. This is a direct result of the intentionally increased viscosity (and adhesion) of the subject device. The washability of the subject device is satisfactory on consideration of the method of removal.
CLINICAL DATA:
There is none applicable
CONCLUSIONS :
The data summarised above indicates that the subject device is substantially equivalent to the predicate device.
Any differences in performance are a result of improvements designed to render the product safer and more effective in clinical use.