(37 days)
Not Found
No
The 510(k) summary describes a temporary dental cement and its dispensing system, with performance testing focused on set times. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a temporary dental cement used for cementing crowns and bridges, which does not meet the definition of a therapeutic device as it is not used for treating or curing a disease or medical condition.
No
The device is a temporary dental cement used for cementing crowns and bridges, which is a treatment/restorative function, not a diagnostic one.
No
The device description explicitly states it is a "syringe dispensing system that dispenses a eugenol free temporary dental cement," indicating it is a physical device with a dispensing mechanism and a material, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporarily cementing crowns and bridges in a dental setting. This is a direct application to the patient's teeth, not for examining specimens derived from the human body.
- Device Description: The device is a syringe dispensing system for dental cement. This is a material used for a physical procedure on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device is a dental material used directly in the mouth.
N/A
Intended Use / Indications for Use
The eugenol free temporary dental cement is used to apply a temporary crown or bridge. It allows for an accurate seating, quick set, removal of excess material from work area , and a rigid set than can still be easily removed when the permanent is ready for application.
Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily cementing crowns and bridges. It provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal of excess material from gingival tissues and undercuts, and a rigid set combined with easy removal of the temporary.
Product codes
EMA
Device Description
The device is a syringe dispensing system that dispenses a eugenol free temporary dental cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The critical performance characteristics of Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement are Initial Set and Final set. Kay-See Dental performed test to assure the product performed to specification.
Specifications: Initial Set - 90 sec +/- 30 sec, Final Set - 3 min +/- 30 sec
Test procedure: Conditions - 75% humidity, 85 degree F, Sampling - 10 random subgroups of three samples each. The catalyst and base components were dispensed and mixed to obtain a .5 gram sample. Using an electronic stop watch, the samples were monitored for initial set ( rubbery consistency) and then for final set (hardened material).
Test results for Initial Set: Min 80 sec, Max 91 sec.
Test results for Final Set: Min 175 sec, Max 196 sec.
Conclusion: The results of this testing provides additional assurance that Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement does provide the important two stage cure and its performance is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
UNTIL eugenol free temporary polymeric composition cementing agent, K884081
Reference Device(s)
Not Found
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
2/05/99
Ka990155
SUMMARY
1
Date Prepared 01/15/99
Submitted by Clark Smith D.M.D.
Kay-See Dental 124 East Missouri Avenue Kansas City, MO 64106
Telephone 800-842-8844 Fax 816-842-3204
Contact Clark Smith D.M.D.
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Trade name - Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement
Common name - Temporary Cement
Classification Name - Dental Cement (872.3275)
Substantial equivalence claimed to - UNTIL eugenol free temporary polymeric composition cementing agent, K884081. Manufactured by SciPharm.
Description of the device.
The device is a syringe dispensing system that dispenses a eugenol free temporary dental cement
Intended use of device.
The eugenol free temporary dental cement is used to apply a temporary crown or bridge. It allows for an accurate seating, quick set, removal of excess material from work area , and a rigid set than can still be easily removed when the permanent is ready for application.
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TECHNOLOGICAL CHARACTERISIC COMPARISON
SciPharm UNTIL
-
- Base: Preparation of bis-GMA Multifunctional methacrylates, polymerization initiator.
-
- Catalyst: Preparation of bis-GMA, multifunctional methacrylates, polymerization initiator.
Hydro-Cast Versa Temp
Base: Preparation of bis-GMA Multifunctional methacrylates polymerization activator.
Catalyst: Preparation of bis-GMA, multifunctional methacrylates, polymerization initiator.
Summary: The technological characteristics of the two devices are identical.
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Discussion NON-CLINICAL PERFORMANCE TESTING AND DATA
The critical performance characteristics of Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement are Initial Set and Final set. Kay-See Dental performed test to assure the product performed to specification.
Specifications:
Initial Set - 90 sec +/- 30 sec
Final Set - 3 min +/- 30 sec
Test procedure:
Conditions - 75% humidity, 85 degree F
Sampling - 10 random subgroups of three samples each
The catalyst and base components were dispensed and mixed to obtain a .5 gram sample. Using an electronic stop watch, the samples were monitored for initial set ( rubbery consistency) and then for final set (hardened material).
| Test results: | Initial Set | Final Set |
|---|---|---|
| Min | 80 sec | 175 sec |
| Max | 91 sec | 196 sec |
Conclusion:
The results of this testing provides additional assurance that Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement does provide the important two stage cure and its performance is substantially equivalent to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294
Re : K990155 Trade Name: Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement Requlatory Class: II Product Code: EMA Dated: January 15, 1999 Received: January 19, 1999
Dear Dr. Clark
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 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. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Dr. Clark
the Act for devices under the Electronic Product Ratiation the Act for devices ander on other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis recei will arrowk) premarket notification. The FDA described in your 510\x) promatics of your device to a legally I marketed predicate device results in a classification for your marketed predicate device to proceed to the market.
If you desire specific advice for your device on our labeling If you debire bpg 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 Compriance at (50) overtising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the office or compiland, "Misbranding by reference to the regulation entification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from chonomiser (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fpa.gov/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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Image /page/7/Picture/0 description: The image shows a stylized, handwritten word that appears to be "KMOISS". The letters are bold and black, contrasting with the white background. The style of the writing is somewhat abstract, making it appear like a logo or a piece of graphic art.
STATEMENT OF INDICATIONS FOR USE
Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily Hydro-Cast Versa-Temp Dagonor P.C. I Versa-Temp provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal le telliporaly, very hast inst suge out what and cultular tissues and undercuts, and a rigid set combined with easy removal of the temporary.
set combined with any, THEN...
Clark Smith D.M.D.
Clark Smith D.M.D
Susan Pennr
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K990154 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)