(24 days)
Not Found
No
The summary describes a temporary dental cement and makes no mention of AI or ML technology.
No
The device is a temporary dental cement used for interim cementation of dental prostheses, which is a restorative rather than therapeutic function.
No
Explanation: The device is a temporary cement for dental restorations, which is a therapeutic product, not a diagnostic one. It is used for interim cementation, not for identifying a disease or condition.
No
The device description clearly identifies the product as a "non-eugenol temporary cement," which is a physical material, 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 for "interim cementation of inlays, crowns and bridges." This is a dental procedure performed directly on a patient's teeth.
- Device Description: The description details a "temporary cement" used in a dental context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a dental material.
N/A
Intended Use / Indications for Use
For temporary application of provisional crowns, bridges, inlays, and onlays.
UltraTemp Firm, Fast and Regular is a non-eugenol temporary cement indicated for interim cementation of inlays, crowns and bridges. It is methacrylate based and does not negatively affect resin bonding. Being water soluble until set, it cleans up easily.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
UltraTemp Firm, Fast and Regular are non-eugenol temporary cements. They are methacrylate based and do not negatively affect resin bonding. Being water soluble until set, they clean up easily. UltraTemp Firm is available in regular and fast set.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Each lot of product must pass internal test specifications prior to release. The results of biocompatibility testing demonstrate that UltraTemp Firm, Fast and Regular are safe and effective when used according to the Instructions for Use.
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
0g0768
SPECIAL 510(K) SUMMARY
APR 1 1 2008
UltraTemp Firm, Fast and Regular
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for UltraTemp Firm, Fast and Regular.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | Diane Rogers |
|---|---|
| Title: | Regulatory Affairs Product Specialist |
| Telephone: | 800-552-5512 x4491, 801-553-4491 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | January 23, 2008 |
Name of the Device
| Trade Name: | |
|---|---|
| Common Name: | |
| Device Classification: | |
| Classification Product Code: |
UltraTemp Firm, Fast and Regular Dental Cement ll EMA
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is UltraTemp (K994261) This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095.
Product Description: UltraTemp Firm, Regular and Fast are non-eugenol temporary cements. They are methacrylate based and do not negatively affect resin bonding. Being water soluble until set, they clean up easily. UltraTemp Firm is available in regular and fast set.
Indications for Use: For temporary application of provisional crowns, bridges, inlays, and onlays.
1
Table 1: Product Comparison
| Property | Predicate:
UltraTemp (K994261) | UltraTemp Firm
Fast and Regular |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Intended Use | Temporary cement | Same |
| Type of material | Polycarboxylate | Methacrylate |
| Characteristics | Temporary Luting/Filling
Material | Same |
| Human factors | Dual Spense Delivery System | Double Barrel
Delivery System |
| Biocompatibility/Safety | Cytotoxicity, Sensitization,
irritation and Genotoxicity
testing passed. Literature and
testing to demonstrate
product is safe when used as
directed | Same |
Technological Characteristics
UltraTemp Firm, Fast and Regular are non-eugenol temporary cements. They are methacrylate based and do not negatively affect resin bonding. Being water soluble until set, they clean up easily. UltraTemp Firm is available in regular and fast set.
Brief Description of Testing Performed
Each lot of product must pass internal test specifications prior to release. The results of biocompatibility testing demonstrate that UltraTemp Firm, Fast and Regular are safe and effective when used according to the Instructions for Use.
Conclusion and Substantial Equivalence
In conclusion, UltraTemp Firm, Fast and Regular, are to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, UT 84095, is substantially equivalent to UltraTemp (K994261), also manufactured by Ultradent Products, Inc. The two products are composed of similar materials, have the same intended use and technological characteristics, and both are safe and effective when used for the indications described.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
APR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diane Rogers Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K080768
Trade/Device Name: UltraTemp Firm, Fast and Regular Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 18, 2008 Received: March 18, 2008
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2- Ms. Rogers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clues
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known):
Device Name:
UltraTemp Firm, Fast and Regular is a non-eugenol temporary Indications for Use: cement indicated for interim cementation of inlays, crowns and bridges. It is methacrylate based and does not negatively affect resin bonding. Being water soluble until set, it cleans up easily.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page_1 of
(Posted November 13, 2003)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: