SmileBond Systems Fast Bite Registration material is used for making impressions of the tech and gums of patients requiring enhancement of the smile and for bite alignment.

Device Description

SmileBond System is a patented process for the delivery of dental bonding composites. The SmileBond process is indicated for both cosmetic enhancement of the smile, and functional improvement of the bite (or chewing system).

Fast-Set Bite Registration is a silicone impression material intended to be placed on an impression tray to reproduce the structures of the teeth and gums of patients requiring the enhancement of the smile and for bite alignment. The impression material is intended to be applied via a dual barrel cartridge system into an impression tray. The clear impression material is used in the lab to make an accurate impression of the final wax up. Once the impression material is set and slightly modified it is taken to the mouth for use in the transfer bonding process.

AI/ML Overview

This 510(k) submission (K132599) concerns the "SmileBond System: Fast-Set Bite Registration Material," which is a dental impression material. The submission establishes substantial equivalence to existing predicate devices, rather than introducing a novel AI-powered diagnostic device.

Therefore, many of the requested categories related to AI performance, such as multi-reader multi-case studies, standalone algorithm performance, training/test set details, and expert adjudication of AI results, are not applicable to this type of device.

Here's the information that can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For dental impression materials, acceptance criteria typically revolve around physical and mechanical properties, as well as biological compatibility. These are usually evaluated through laboratory testing following relevant ISO standards. However, the provided summary does not detail specific acceptance criteria or performance metrics (e.g., accuracy, tear strength, dimensional stability, working time, setting time).

Instead, the submission focuses on demonstrating substantial equivalence based on:

Intended Use: Making impressions of teeth and gums for smile enhancement and bite alignment.
Technological Characteristics: Silicone impression material, dual-barrel cartridge delivery, used with an impression tray.
Comparison to Predicate Devices: Stating that the material is comparable to previously cleared silicone impression materials.

Acceptance Criterion (Inferred from device type)	Reported Device Performance
Material Type	Silicone impression material
Delivery System	Dual-barrel cartridge system
Application Method	Applied into an impression tray
Purpose	Reproduces structures of teeth and gums for smile enhancement and bite alignment
Substantial Equivalence	Declared substantially equivalent to predicate devices (K801830 and K120013) based on intended use and technological characteristics. Implicitly meets the performance and safety profiles of these predicates.

2. Sample Size Used for the Test Set and Data Provenance

Since this is a dental impression material, the "test set" would typically refer to samples of the material used in laboratory or potentially in-vivo/clinical performance studies (e.g., for physical properties, biocompatibility).

The provided document does not specify sample sizes for any performance testing.
Data Provenance: The document does not provide details on the origin of any performance data. The device is manufactured by Crown Delta under a previous 510(k) (K801380) for Millennium Company, suggesting that performance data, if generated, might refer to that previous clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to a dental impression material. "Ground truth" in this context would refer to objective measurements of the material's properties (e.g., dimensional accuracy, tear strength) obtained through standardized laboratory tests, not expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable to a dental impression material. Adjudication is relevant for diagnostic interpretations, not for material property assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable as this is not an AI/diagnostic device that improves human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

For an impression material, the "ground truth" would be objective measurements of its physical and mechanical properties (e.g., working time, setting time, dimensional stability, elasticity, tear strength) typically established against ISO standards (e.g., ISO 4823 for elastomeric impression materials). The provided document does not explicitly state which specific ground truth measurements were used, but it implicitly relies on the material meeting the standards established for its predicate devices by Crown Delta.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as this is not an AI/machine learning device.

Summary

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i32599

510(k) Summary

FEB 2 5 2014

[as required by section 807.92(c)]

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

General Information

Submitted by:	Millennium Company LLC2524 Lake Lansing RoadLansing, MI 48912
	Phone: +1 (517) 282-3811Fax: +1 (517) 485-3763Email: drbillv@smilebond.com
Contact Person:	Stephen J. Goldner, JD, RACRegulatory Affairs Associates, Inc.40701 Woodward Avenue, Suite 102Bloomfield Hills, MI 48304
	Phone: +1 (248) 712-0356Fax: +1 (203) 413-4320Email: sgoldner@regaffairs.net
Date Prepared:	February 6, 2014
Device Name
Trade Name:	Fast-Set Bite Registration Material;SmileBond System
Common Name(s):	Impression Material
Classification
Regulation:	21 CFR §872.3660
Class:	II
Product Code:	ELW

Classification Name: Impression material limpression material Regulation Name:

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Predicate Devices

Silicone Impression Material	K801830	Crown Delta
TempSpan Clear Matrix Material	K120013	Pentron Clinical

Device Description

Indication for Use

SmileBond Systems Fast Bite Registration Material impression material is indicated for making impressions of the teeth and gums of patients requiring enhancement of the smile and for bite alignment.

Intended Use

Fast-Set Bite Registration Material is intended for the enhancement of the smile and bite alignment. SmileBond System is intended for

. cosmetic correction;
. malpositioned teeth:
tooth discoloration, incorrect shading; .
. anatomical malformation;
attrition, abrasion, erosion; and .
. decay repair.

Comparison to Predicate Devices

TempSpan Clear Matrix Material is a clear, medium viscosity vinyl polysiloxane material that reproduces fine detail for the fabrication of extremely accurate provisional restorations

Crown Delta's silicone impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production of restorative prosthetic devices. The impression material is intended to be applied via a dual barrel cartridge system either into an impression tray or directly onto the patient's teeth.

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mouth for use in the transfer bonding process.

The Fast Bite Registration Material is manufactured by Crown Delta under its 510(k) K801380 for Millennium Company. The product is labeled with the Own Brand Label (OBL) for SmileBond System.

Conclusion

The SmileBond System kit is comprised of legally marketed devices. The SmileBond process does not affect the substantial equivalence of the Fast-Set Bite Registration Material to the cited predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

Millennium Company LLC C/O Mr. Stephen J. Goldner, JD, RAC Regulatory Affairs Associates, Inc. 40701 Woodward Avenue, Suite 102 Bloomfield Hills, MI 48304

Re: K132599

Trade/Device Name: SmileBond System: Fast-Set Bite Registration Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW, OFW Dated: November 27, 2013 Received: December 6, 2013

Dear Mr. Goldner:

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 - Mr. Goldner

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 (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/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/Industry/default.htm.

Sincerely yours,

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for

Erin I. Keith, 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Fonn Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132599

Device Name

SmileBond System Fast Bite Registration Material

Indications for Use (Describe)

SmileBond Systems Fast Bite Registration material is used for making impressions of the tech and gums of patients requiring enhancement of the smile and for bite alignment.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Mary S. Runner - 2014.02.27 08:25:13-05'00'
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FORM FDA 3881(9/13)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF01-001
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Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).