(40 days)
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No
The summary describes a traditional dental cement and lacks any mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is a dental cement used for cementing dental restorations and orthodontic appliances. It is not designed to treat or cure a disease or medical condition, which is the primary function of a therapeutic device.
No
The device is a dental cement used for binding dental prosthetics and appliances, not for diagnosing medical conditions.
No
The device description clearly states it is a "Glass Ionomer (Polyalkenoate) Luting Dental Cement (Powder/Liquid Kit and Injectable Capsules)", which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to cementing dental restorations and appliances within the patient's mouth. This is a direct application to the body, not an examination of samples taken from the body.
- Device Description: The description of a dental cement further supports its use in a clinical dental setting for direct application.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting
Therefore, this device is a dental material used for restorative and orthodontic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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- Cementing crowns
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-
-
- Cementing bridges
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-
- Cementing inlays 3)
-
- Cementing orthodontic appliances 4)
Product codes
EMA
Device Description
GlasIonomer Cement CX Plus™
Glass Ionomer (Polyalkenoate) Luting Dental Cement (Powder/Liquid Kit and Injectable Capsules)
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
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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)
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Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 24 1998
Mr. Thomas D. Yankelitis Product Manager and Official Correspondent Shofu® Dental Corporation 4025 Bohannon Drive Menlo Park, California 94025-1096
Re : K982461 GlasIonomer Cement CX Plus™ Trade Name: Regulatory Class: II Product Code: EMA Dated: July 14, 1998 Received: July 15, 1998
Dear Mr. Yankelitis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Yankelitis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
S. Butman for
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
GlasIonomer Cement CX Plus™
Glass Ionomer (Polyalkenoate) Luting Dental Cement (Powder/Liquid Kit and Injectable Capsules)
Indications for Use
-
-
- Cementing crowns
-
-
-
- Cementing bridges
-
-
- Cementing inlays 3)
-
- Cementing orthodontic appliances 4)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21CFR 801.109)
Over-The-Counter Use
Susan Runno
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ G & 24 le