(75 days)
Not Found
No
The device description and intended use clearly describe a temporary dental cement, a material-based product, with no mention of software, algorithms, or any computational processing that would involve AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a temporary dental cement used for luting crown and bridge prostheses, not for treating a disease or condition.
No
The device is a temporary dental cement used for retention, not for diagnosing conditions.
No
The device description clearly states it is a two-part paste provided in syringe-like cylinders, indicating a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cementing (luting) of crown and bridge prostheses to natural tooth abutments." This is a direct application within the mouth for a dental procedure.
- Device Description: The device is a temporary dental cement used for retention of prostheses. It's a material applied directly to the anatomical site.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimens.
Therefore, the function and application of Steri-Oss' ImProv Temporary Dental Cement clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Steri-Oss' ImProv Temporary Dental Cement serves as a cement for the temporary retention of crown and bridge prostheses. The cement is an anaerobic two part paste which self-cures upon mixing. The product is provided in two syringe-like cylinders made of a polyalkylene material, one containing 10 grams of cement Part A and one containing 10 grams of cement Part B.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural tooth abutments
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 3 1998
Ka82400
Steri-Oss' ImProv Temporary Dental Cement Original 510(k) Submission
Section 6
510(k) Summary
Manufacturer Information:
Submitter's Name: Steri-Oss Inc. 22895 Eastpark Drive Address: Yorba Linda, CA 92887 U.S.A.
Jeff Hausheer, Ph.D. Contact's Name: Requlatory Affairs Specialist
714-282-4800 Phone:
714-988-9236 Fax:
Date Prepared:
July 1998
Device Name:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Crown and Bridge Cement Common Name: Trade Name: Steri-Oss' ImProv Temporary Dental Cement Classification Name: Dental Cement
Predicate Device:
Substantial equivalence is claimed to Steri-Oss' Untill Implant Cement (510(k) K972965), cleared on November 7, 1997, and intended for cementation (luting) of an implant prosthesis, and to Scientific Pharmaceutical's Interim Cement (510k) K884081, cleared on December 2, 1988, and intended for cementation (luting) of crown and bridge prostheses to natural tooth abutments .
Nateeth.doc
1
Steri-Oss' ImProv Temporary Dental Cement Original 510(k) Submission
Section 6 (continued)
510(k) Summary
Device Description:
How the device functions:
Steri-Oss' ImProv Temporary Dental Cement serves as a cement for the temporary retention of crown and bridge prostheses. The cement is an anaerobic two part paste which self-cures upon mixing. The product is provided in two syringe-like cylinders made of a polyalkylene material, one containing 10 grams of cement Part A and one containing 10 grams of cement Part B.
Intended Use:
Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.
Comparison to Predicate
The following table provides a comparison of the technological characteristics of Steri-Oss' ImProv Temporary Dental Cement to the predicate devices.
| Characteristic | Predicate 1: Interim Cement | Predicate 2: Until Implant Cement | New Product: ImProv |
|---|---|---|---|
| Curing | Anaerobic Self-curing | Anaerobic Self-curing | Same |
| System | Two part system | Two part system | Same |
| Cement Base | Resin filled | Resin filled | Same |
Performance Data
Not applicable
Page 2 of 2
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1998
Jeff Hausheer, Ph.D. Regulatory Affairs Specialist Steri-Oss, Incorporated 22895 Eastpark Drive Yorba Linda, California 92887
Re : K982400 Steri-Oss' ImProv Temporary Dental Cement Trade Name: Regulatory Class: II Product Code: EMA Dated: July 10, 1998 Received: July 10, 1998
Dear Dr. Hausheer:
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 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. ਖ 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 ------
3
Page 2 - Dr. Hausheer
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 leqally 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 yours,
Susan Kunney
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Steri-Oss' ImProv Temporary Dental Cement Original 510(k) Submission
Section 8
Indications for Use
Page _1_of _1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Steri-Oss' ImProv Temporary Dental Cement
Indications For Use:
Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Russo | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K982400 |
| Prescription Use | ✓ |
|---|---|
| ------------------ | ---------------------------------------------------- |
OR Over-The-Counter Use _____ (Per 21 CFR 801.109)
(Optional Format 1-2-96)