(97 days)
K111855 Hy-Bond Resiglass
K111855 Hy-Bond Resiglass
No
The device description and performance studies focus on the chemical and physical properties of a dental cement, with no mention of AI or ML technologies.
No.
The device is a dental cement intended for restoring natural teeth, not for treating or curing a disease or condition.
No
The device description and intended use indicate that UltraCem™ is a dental cement used for bonding restorations and orthodontic bands to teeth, not for diagnosing medical conditions. The performance studies also focus on physical properties related to its function as a cement, such as bond strength and setting time, rather than diagnostic accuracy.
No
The device description clearly states that UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement supplied in a syringe or bottles, indicating it 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 is for the cementation of dental restorations and orthodontic bands to natural teeth. This is a direct application within the body (in vivo) for structural support and attachment.
- Device Description: The device is a cement, a material used for bonding.
- Lack of In Vitro Testing: The description of performance studies focuses on bench tests related to the physical properties of the cement (bond strength, setting time, etc.) and a literature study. There is no mention of testing biological samples (blood, tissue, etc.) outside of the body to diagnose a condition or provide information about a physiological state.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. UltraCem™ does not fit this description.
N/A
Intended Use / Indications for Use
UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.
Product codes
EMA, DYH
Device Description
UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement. UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth
Indicated Patient Age Range
all ages that need a restoration or repair as prescribed by a dentist. The product can be used on any age patient when treatment is prescribed by a dentist.
Intended User / Care Setting
dentist
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 following bench tests were conducted during the R & D phase on UltraCem™ and compared to K111855 Hy-Bond Resiglass:
- Shear bond: This in-vitro test determines how well the material enhances the bonding to various surfaces compared to both the Hy-Bond system and the UltraCem™ system. UltraCem™ is comparable to Hy-Bond which is currently on the market and is well-received.
- Working-Setting Time: The working time was determined to be when the product began to display gel-like polymerization properties. The setting time was determined to be the time when the product was polymerized to the point when the mass could be moved as a whole.
- Film Thickness: A micrometer was zeroed on two glass cover slips. A small drop of product was placed between the cover slips, which were then placed underneath a load for several seconds. The thickness was measured in microns and recorded.
- Flexural Strength: Samples were prepared with each product and allowed to cure, then stored in 40° water for 24 hours. The samples were tested and the strengths were recorded.
- Radiopacity: Specimens were allowed to cure then placed under an X-Ray machine and compared to determine how well the products can be viewed in an X-Ray.
Clinical Summary: A complete Clinical Summary of UltraCem™ is included in Section 20. We conducted a literature study to show substantial equivalence in safety and effectiveness of this product. The device has the same technological characteristics compared to K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078.
Key Metrics
Not Found
Predicate Device(s)
K111855 Hy-Bond Resiglass
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
OCT 2 4 2013
Section 5
Traditional 510(k) Summary
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 .92.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Contact Person: Title: Telephone: FAX: Date Summary Prepared:
Diane Rogers Manager of Regulatory and Global Affairs (800) 552-5512 x4491, (801) 553-4491 (801) 553-4609 July 18, 2013
Name of the Device
UltraCem™ Trade Name: Dental Cement Common Name: Device Classification: Class II Classification Product Code: EMA
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is: K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078
UltraCem™ is very similar to our predicate device in that both devices are intended to be used as dental cements.
Indications for Use: UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.
1
Product Description: UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement.
Technological characteristics
..
| UltraCem™ | | UltraCem™ is indicated for
cementation of indirect
restorations (including inlays,
onlays, crowns and bridges)
made of metal, porcelain
fused to metal, zirconia, and
resin to natural teeth. This
product is also intended for
cementation of orthodontic
bands to natural teeth. |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hy-Bond Resiglass | 111855 | Hy-Bond Resiglass is
intended for
cementation of
restorations (including
inlay, crown and
bridge) made of metal,
ceramics (porcelain)
and resin to natural
teeth. This product is
also intended for
cementation of
orthodontic appliances
(metal bracket,
ceramic bracket, etc)
to natural teeth. |
| Characteristics | Glass ionomer cement | Glass ionomer cement |
| Human Factors | Syringe delivery or brush and
bottle | Brush and bottle |
| Biocompatibility | Not performed as the formula
is the same as our predicate
and then the product is
placed in our own syringe
delivery system, or used in
bottles | ISO 10993
Cytotoxicity
Sensitization
Irritation
Genotoxicity |
2
UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.
Hy-Bond Resiglass is supplied in two part bottles to be mixed with application brushes then directly applied to surfaces.
The patient population is intended for all ages that need a restoration or repair as prescribed by a dentist. UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement.
Brief Description of Testing Performed
The following bench tests were conducted during the R & D phase on UltraCem™ and compared to K111855 Hy-Bond Resiglass. Final test results are in Section 18 "Bench Testing".
Shear bond: This in-vitro test determines how well the material enhances the bonding to various surfaces compared to both the Hy-Bond system and the UltraCem™ system. UltraCem™ is comparable to Hy-Bond which is currently on the market and is well-received.
Working-Setting Time: The working time was determined to be when the product began to display gel-like polymerization properties. The setting time was determined to be the time when the product was polymerized to the point when the mass could be moved as a whole.
Film Thickness: A micrometer was zeroed on two glass cover slips. A small drop of product was placed between the cover slips, which were then placed underneath a load for several seconds. The thickness was measured in microns and recorded.
Flexural Strength: Samples were prepared with each product and allowed to cure, then stored in 40° water for 24 hours. The samples were tested and the strengths were recorded.
Radiopacity: Specimens were allowed to cure then placed under an X-Ray machine and compared to determine how well the products can be viewed in an X-Ray.
Clinical Summary
A complete Clinical Summary of UltraCem™ is included in Section 20. We conducted a literature study to show substantial equivalence in safety and effectiveness of this product. The product can be used on any age patient when treatment is prescribed by a dentist. The device has the same technological characteristics compared to K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078.
Hy-Bond Resiglass has been widely used by numerous dentists in the dental industry.
3
The intended purpose of UltraCem™ has been demonstrated by a combination of in-house testing and side-by-side comparisons to a predicate device currently on the market. Results of our bench testing indicates that UltraCem™ is substantially equivalent to the predicate device currently on the market. (Test results are in Section 18 Bench Testing).
Summary Risk/Benefit Review
Considering the safe history of our predicate, K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078 UltraCem™ is substantially equivalent to our predicate device. Our research indicates that our predicate has been used by many dentists and large group practices in the United States and purchased by a large number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of the predicate product.
UltraCem™ was not tested for biocompatibility as our predicate (K111855) has the same exact formula and ingredients and their product was tested in Cytotoxicity, Sensitization, Irritation and Genotoxicity tests according to ISO 10993-1.
In conclusion, UltraCem™ has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and determined to be substantially equivalent in safety and effectiveness of similar products used for the same indication. Following the clinical review as documented above, Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition and the association with its use constitutes acceptable risks when weighed against the benefits to the patient. Therefore, the product is substantially equivalent and may be released to the market.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2013
Ultradent Products, Incorporated C/O Ms. Diane Rogers Regulatory and Global Affairs Manager 505 West 10200 South South Jordan, Utah 84095
Re: K132255
Trade/Device Name: UltraCem™ Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA. DYH Dated: August 8, 2013 Received: August 9, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.
5
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 18 of 492
Statement of Indications for Use
510(k) Number (if known): __
Device Name: UltraCem™
Indications for Use:
.
UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.
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 ___ of _1
Mary S. Runner -S
Susan Runner DDS, PA 2013.10.24
11:07:08 -04'00'
(Posted November 13, 2003)