(79 days)
No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No.
The device is a dental cement used for permanent cementation of veneers, which is an aesthetic and restorative procedure, not a therapeutic treatment.
No
Explanation: The device is a dental cement used for permanent cementation of veneers, which is not a diagnostic function. It is a material used in a restorative dental procedure.
No
The device description clearly states it is a "light-cured, moderately viscous, permanent resin cement," 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 is for the permanent cementation of dental veneers. This is a direct treatment/restoration procedure performed on a patient's teeth.
- Device Description: The device is a resin cement used to bond materials to teeth.
- 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.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the mouth for a restorative dental procedure.
N/A
Intended Use / Indications for Use
PermaShade Veneer Cement can be used for permanent cementation of porcelain, zirconia, composite and other indirect veneers.
Product codes
EMA
Device Description
PermaShade Veneer Cement is a light-cured, moderately viscous, permanent resin cement. It is 66.5% filled by mass, is available in four shades, and has very low shrinkage and color change properties.
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
Dental professional
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
PermaShade Veneer Cement has been tested against the predicates listed above as outlined in ISO 4049 and demonstrated equivalent in vitro performance. Biocompatibility testing shows that the product is safe when used as instructed by a dental professional.
Key Metrics
Not Found
Predicate Device(s)
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
Ultradent Products, Inc. Premarket Submission for PermaShade™ Veneer Cement Traditional 510(k)
SEP 1 6 2011
Section 5: 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.
l. Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | Corey Jaseph, RAC |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | 800-552-5512 x4420, 801-553-4420 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | 15 SEP 2011 |
11. Name of the Device
| Trade Name: | PermaShade Veneer Cement |
|---|---|
| Common Name: | Dental Cement |
| Device Classification: | 2 |
| Classification Product Code: | EMA |
| Regulation No. | 872.3275 (dental cement) |
III. Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate devices are PermaFlo, manufactured by Ultradent (K974413), and Variolink Veneer, manufactured by Ivoclar Vivadent (K931309).
IV. Device Description:
PermaShade Veneer Cement is a light-cured, moderately viscous, permanent resin cement. It is 66.5% filled by mass, is available in four shades, and has very low shrinkage and color change properties.
1
Ultradent Products, Inc. Premarket Submission for PermaShade™ Veneer Cement Traditional 510(k)
V. Statement of intended use:
PermaShade Veneer Cement can be used for the permanent cementation of porcelain, zirconia, composite, and other indirect veneers.
VI. Comparison of technological characteristics
Table 5-1: Substantial equivalence comparison
| Characteristic | PermaFlo
Ultradent
K974413 | Variolink Veneer
Ivoclar Vivadent
K931309 | PermaShade
Veneer Cement
Ultradent
NEW DEVICE |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | PermaFlo can be used for:
- Anterior and posterior
restorations, such as Class I, II,
III, IV, and V - Luting translucent inlays and
onlays. - Direct veneers and other
restorative procedures. - Restoring missing subgingival
tooth structure prior to
endodontic procedures (this is
referred to as the "donut"
technique) | Adhesive luting of
ceramic and
composite
restorations | Permanent
cementation of
indirect porcelain,
zirconia, and
composite
veneers |
| Intended user | Dental professional | Same | Same |
| Composition of
materials | Dimethacrylate-based, filled
resin | Same | Same |
| Type of cure | Photochemical | Same | Same |
| Percent Fill | 68% (m/m) | 47 - 66% (m/m) | 66% (m/m) |
| Filler Particle
Size | Average 700 nm | 40-300 nm | 13 - 700 nm |
| Delivery system | Syringe | Same | Same |
| Multiple Shades | Yes | Same | Same |
| Physical
properties | Tested and characterized
according to ISO 4049 | Same | Same |
| Biocompatibility | Tested per ISO 10993-1 and
ISO 7405 | Same | Same |
PermaShade Veneer Cement was designed to be a strong and esthetic option with high color stability for cementing indirect veneers. PermaShade Veneer Cement is a similar material used in the same way by the same types of users as the identified predicate devices, introducing no new safety or efficacy questions. It has been tested against the predicates listed above as outlined in ISO 4049 and demonstrated equivalent in vitro
2
Ultradent Products, Inc.
Premarket Submission for PermaShade™ Veneer Cement Traditional 510(k)
performance. Biocompatibility testing shows that the product is safe when used as instructed by a dental professional. In summary, this submission demonstrates that PermaShade Veneer Cement is safe and effective and performs equivalently to the identified predicates for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an abstract human figure with three flowing lines extending from the head, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MI) 20993-0002
Ms. Corev Jaseph Regulatory Affairs Manager Ultradent Products. Incorporated 505 West 10200 South South Jordan. Utah 84095
FP 1 6 231
Re: K111836
Trade/Device Name: PermaShade Veneer Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: June 28, 2011 Received: June 29, 2011
Dear Ms. Jaseph:
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 Federal Register.
4
Page 2 - Ms. Jaseph
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetv/ReportaProblem/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/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
hr for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ultradent Products, Inc. Premarket Submission for PermaShade™ Veneer Cement Traditional 510(k)
Section 4: Statement of Indications for Use
510(k) Number (if known):
Device Name: PermaShade Veneer Cement
Indications for Use: PermaShade Veneer Cement can be used for permanent cementation of porcelain, zirconia, composite and other indirect veneers.
Prescription Use _X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Susan Runner
..
Page 1 of 1 _ _ _
(Posted November 13, 2003)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111836
Page 14 of 285