(50 days)
Not Found
Not Found
No
The 510(k) summary describes a dental cement and does not mention any AI or ML capabilities.
No.
The device is a dental cement used for the mechanical attachment of dental prosthetics, which is not considered a therapeutic function.
No
The device is described as a cement ("Cem") for securing dental work like crowns and bridges, as well as root canal posts and orthodontic bands. Its function is to hold things in place, not to diagnose medical conditions by identifying diseases, conditions, or injuries.
No
The 510(k) summary describes a cement for dental restorations, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the cementation of dental restorations (crowns, bridges, inlays, etc.) and orthodontic bands. This is a direct application within the body (or on structures within the body like teeth), not a test performed on samples taken from the body to diagnose a condition.
- Device Description: "Protec Cem" is a cement, consistent with the intended use of bonding materials in dentistry.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
Therefore, Protec Cem is a dental cement used for bonding, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intended Use: Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.
Product codes
EMA
Device Description
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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
Not Found
Intended User / Care Setting
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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
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Key Metrics
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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 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 representation of a human figure, with three overlapping profiles suggesting a family or community.
ﺼﺤﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Mr. Peter P. Mancuso ·Requlatory/Quality Assurance Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
Re : K980922 Trade Name: Protec Cem. Requlatory Class: II Product Code: EMA Dated: March 9, 1998 Received: March 11, 1998
Dear Mr. Mancuso:
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, Druq, 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 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. A substantially equivalent determination assumes compliance with ma 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
1
Page 2 - Mr. Mancuso
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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.qov/cdrh/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
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Page 1 of 1
| 510(k) Number (if known): | Not Known K980922 |
|---|---|
| Device Name: | Protec Cem |
Indications For Use:
Intended Use: Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swoon Purves
(Division Sign-Off) Division of Donui. Infection Control, and General Inspitat 510(k) Number
Prescription Use (Per 21 CFR 801.109)
・・・
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)