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.

AI/ML Overview

The provided submission describes a dental cement, not an AI/ML powered medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML is not applicable. The document discusses a Traditional 510(k) for a dental cement (PermaShade Veneer Cement) and compares its characteristics and performance to legally marketed predicate devices, PermaFlo and Variolink Veneer, to establish substantial equivalence.

However, I can extract the information provided regarding the device's characteristics and performance testing in a general sense, aligning with the spirit of the request as much as possible for a non-AI/ML device.

Acceptance Criteria and Device Performance for PermaShade™ Veneer Cement

Characteristic	Acceptance Criteria (Predicate Reference)	Reported Device Performance (PermaShade Veneer Cement)
Intended Use	Permanent cementation of ceramic and composite restorations (from Variolink Veneer's intended use listed).	Permanent cementation of indirect porcelain, zirconia, and composite veneers.
Intended User	Dental professional (same as predicates).	Dental professional.
Composition	Dimethacrylate-based, filled resin (same as predicates).	Dimethacrylate-based, filled resin.
Type of Cure	Photochemical (same as predicates).	Photochemical.
Percent Fill (m/m)	68% (for PermaFlo) and 47-66% (for Variolink Veneer).	66%.
Filler Particle Size	Average 700 nm (for PermaFlo) and 40-300 nm (for Variolink Veneer).	13 - 700 nm.
Delivery System	Syringe (same as predicates).	Syringe.
Multiple Shades	Yes (same as predicates).	Yes (available in four shades).
Physical Properties	Tested and characterized according to ISO 4049 (Same as predicates).	Tested against predicates as outlined in ISO 4049; demonstrated equivalent in vitro performance.
Biocompatibility	Tested per ISO 10993-1 and ISO 7405 (Same as predicates).	Tested per ISO 10993-1 and ISO 7405; product is safe when used as instructed.

Study Information (Based on the provided text, adapted for a non-AI/ML device):

The submission indicates that PermaShade Veneer Cement was tested to demonstrate substantial equivalence to the predicate devices, PermaFlo and Variolink Veneer.

Sample Size used for the test set and data provenance:
- The document states that the device was "tested against the predicates listed above as outlined in ISO 4049" and demonstrated "equivalent in vitro performance."
- Specific sample sizes for these tests are not provided in the excerpt.
- The data provenance is in vitro testing, likely conducted internally by Ultradent Products, Inc. No country of origin of the data is specified beyond the company's location in South Jordan, Utah, USA. The testing methodology followed an international standard (ISO 4049).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the evaluation of a dental cement's physical and biocompatibility properties typically relies on standardized laboratory tests and measurements rather than expert human interpretation of images or clinical data for ground truth.
Adjudication method for the test set:
- This is not applicable as there is no mention of human-reviewed test sets or adjudication for this device's evaluation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as the device is a dental cement, not an AI/ML system, and therefore, no MRMC studies or AI assistance are mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a dental cement, not an algorithm.
The type of ground truth used:
- For physical properties, the "ground truth" would be established by standardized laboratory measurements (e.g., strength, shrinkage, color change) according to ISO 4049, with comparison to the performance of predicate devices.
- For biocompatibility, the "ground truth" is established by standardized biological evaluation methods described in ISO 10993-1 and ISO 7405.
The sample size for the training set:
- This question is not applicable as the device is a dental cement and does not utilize a training set in the context of AI/ML.
How the ground truth for the training set was established:
- This question is not applicable as the device is a dental cement and does not utilize a training set in the context of AI/ML.

Summary

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K111836

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.

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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	PermaFloUltradentK974413	Variolink VeneerIvoclar VivadentK931309	PermaShadeVeneer CementUltradentNEW DEVICE
Intended Use	PermaFlo can be used for:1. Anterior and posteriorrestorations, such as Class I, II,III, IV, and V2. Luting translucent inlays andonlays.3. Direct veneers and otherrestorative procedures.4. Restoring missing subgingivaltooth structure prior toendodontic procedures (this isreferred to as the "donut"technique)	Adhesive luting ofceramic andcompositerestorations	Permanentcementation ofindirect porcelain,zirconia, andcompositeveneers
Intended user	Dental professional	Same	Same
Composition ofmaterials	Dimethacrylate-based, filledresin	Same	Same
Type of cure	Photochemical	Same	Same
Percent Fill	68% (m/m)	47 - 66% (m/m)	66% (m/m)
Filler ParticleSize	Average 700 nm	40-300 nm	13 - 700 nm
Delivery system	Syringe	Same	Same
Multiple Shades	Yes	Same	Same
Physicalproperties	Tested and characterizedaccording to ISO 4049	Same	Same
Biocompatibility	Tested per ISO 10993-1 andISO 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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.