(55 days)
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No
The description details a traditional dental cement and its chemical composition and uses, with no mention of software, algorithms, or any technology that could incorporate AI/ML.
No
The device is used for the attachment of indirect restorations and appliances to the teeth, such as inlays, crowns, bridges, facings, and orthodontic brackets, which are restorative or structural applications, not therapeutic.
No
Explanation: The device, Zinc Phosphate, is described as a cement and luting agent used for attaching dental restorations and appliances, not for diagnosing medical conditions.
No
The device description clearly states it consists of powder and liquid in two separate bottles, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a "luting agent" for the "attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets." This is a direct application within the body (in vivo) for structural support and attachment.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform any such diagnostic testing on biological samples.
The device is a dental cement used for mechanical attachment within the oral cavity, which is an in-vivo application, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
Zinc Phosphate is the oldest of the cementation agents and thus the one with the longest track record (introduced in 1878). It serves as a standard by which newer systems can be compared. It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent.
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
teeth
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): 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
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§ 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.
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Image /page/0/Picture/2 description: The image contains a combination of abstract shapes and text. On the left side, there is a stylized, dark shape that resembles a flourish or decorative element. To the right, there is a horizontal line, and below that, there is some text, although it is difficult to discern the exact letters or words due to the image quality.
OCT 22 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra Olson Official Correspondent Medental International 1246 Clear Creek Road Evergreen, Colorado 80439
Re : K983018 Trade Name: Zinc Phosphate Cement Regulatory Class: II Product Code: EMA August 25, 1998 Dated: Received: August 28, 1998
Dear Ms. Olson:
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 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 general controls provisions The general controls provisions of the Act of the Act. include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Olson
This letter will allow you to begin 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" (21 CFR 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/dsmamain.html".
Sincerely
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MEDENTAL INTERNATIONAL 1246 Clear Creek Road Evergreen, CO 80439 Establishment # 1723973
14983018 510(k) Number: Unknown
Device Name: Zinc Phosphate Cement
Indications for Use:
Zinc Phosphate is the oldest of the cementation agents and thus the one with the longest track record (introduced in 1878). It serves as a standard by which newer systems can be compared. It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.
Yewed Sheppon
(Division Sign Off)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K943018 510(k) Number.