(64 days)
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Not Found
No
The summary describes a dental restorative material and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is used for treating cavities and involves free-hand veneering, which are restorative procedures rather than therapeutic in the sense of treating or preventing diseases.
No
The 'Intended Use' section describes the device's use for treating various dental cavities and for free-hand veneering, which are all treatment procedures, not diagnostic ones.
No
The provided 510(k) summary describes a device for dental cavity preparation and restoration, which are physical procedures requiring hardware tools and materials. There is no mention of software as the primary or sole component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for dental procedures within the mouth (filling cavities, veneering). This is a direct interaction with the patient's anatomy.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. They are used outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, laboratory procedures, or providing diagnostic information based on such analysis.
The device described is a dental material or instrument used for restorative and cosmetic dental procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
Product codes
EMA, EBF
Device Description
AHL Generic Glass Ionomer Aesthetic Restorative
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental professional such as DDS or DMD
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Public Health Service
- 9 2002
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Advanced Healthcare Limited C/O Mr. Perry Kashfian Pearson Dental Supply Company 13161 Telfair Avenue Sylmar, California 91342
Re: K020376
Trade/Device Name: AHL Generic Glass Ionomer Aesthetic Restorative Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and EBF Dated: January 31, 2002 Received: February 04, 2002
Dear Mr. Kashfian:
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. Perry Kashfian
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 (QS) 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 yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
AHL Generic Glass Ionomer Aesthetic Restorative
ATTACHMENT #4
INDICATIONS FOR USE
510(k) Number: number not yet assigned (KOLO376 )
AHL Generic Glass Ionomer Aesthetic Restorative Device Name:
INDICATIONS : Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
Susan Rianney
n - ( 15-5) ntal, Infection Control,
510 (k)