(77 days)
Not Found
Not Found
No
The summary describes a dental etching product and does not mention any AI or ML capabilities.
No
The device is described as an etching agent used for dental restorations and bonding, which is a material used in a process rather than a device designed to treat or prevent disease or injury.
No
The "Intended Use / Indications for Use" section describes the device's use in various dental restorative and bonding procedures, such as composite restorations, adhesive cementation, and fissure sealings. These are treatment procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The intended use describes a material (etching gel) used in dental procedures, not a software application. The summary lacks any mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product used for dental procedures like etching enamel for composite restorations, cementing various dental prosthetics, bonding orthodontic attachments, and fissure sealings. These are all procedures performed directly on the patient's teeth and involve physical or chemical interaction with the tooth structure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The "in vitro" part means "in glass" or "in the lab," indicating testing outside of the living organism.
The description of E.TCHING 15 clearly indicates it's used in vivo (within the living body) for dental procedures, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
E.TCHING 15 is used in the enamel or total etch techniques for
Composite restorations
Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts.
Splints
Bonding of orthodontic attachments Fissure sealings
Contra indications:
If the stipulated working technique cannot be used, the material should not be applied.
Etchant 15 may dissolve Glass ionomer based bases/liners.
Product codes
EBF
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional such as DDS or DMD.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 22 2002
AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260
Re: K022975
Trade/Device Name: ETCHING 15 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 5, 2002 Received: September 6, 2002
Dear Mr. Ingersoll:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Ingersoll
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21.CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Patience Cucumitfor
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Generatorgatan 8 S .195 €0 Marsta Sweden +046 8 591 210 20 none +046 8 591 161 83
5022975
510 (k) ETCHING 15 ATTACHMENT #4
INDICATIONS FOR USE
I idications:
E.TCHING 15 is used in the enamel or total etch techniques for
Composite restorations
Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts.
Splints
Bonding of orthodontic attachments Fissure sealings
Contra indications:
If the stipulated working technique cannot be used, the material should not be applied.
Etchant 15 may dissolve Glass ionomer based bases/liners.
-or use only by dental professional such as DDS or DMD. Not for use by general oublic or OTC.
Dr. Robert Shatz for Dr. Susan Huppert
Division Sian-Off Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K022975