(189 days)
Not Found
No
The summary describes a silicone impression material and delivery system, with no mention of AI or ML capabilities.
No
The Fast Bite Registration material is used for making impressions of teeth and gums, which is a diagnostic or procedural aid, not a therapeutic intervention itself. Its purpose is to aid in the creation of dental devices for cosmetic enhancement and bite alignment, but it does not directly treat a disease or condition.
No
This device is an impression material used to reproduce the structures of teeth and gums for cosmetic enhancement and bite alignment, which is a manufacturing process rather than a diagnostic one.
No
The device description explicitly states it is a "silicone impression material" and is applied via a "dual barrel cartridge system into an impression tray," indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SmileBond Systems Fast Bite Registration material is used for making impressions of teeth and gums. This is a physical process of creating a mold of anatomical structures.
- Intended Use: The intended use is for making impressions for smile enhancement and bite alignment, which are dental procedures, not diagnostic tests performed on bodily fluids or tissues.
- Device Description: The description clearly states it's a silicone impression material used to reproduce the structures of the teeth and gums.
The device is a dental material used for creating physical impressions, not for analyzing biological samples to diagnose or monitor a medical condition.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ELW, OFW
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth and gums
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)
Not Found
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
§ 872.3660 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).
0
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 LLC
2524 Lake Lansing Road
Lansing, MI 48912 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +1 (517) 282-3811
Fax: +1 (517) 485-3763
Email: drbillv@smilebond.com |
| Contact Person: | Stephen J. Goldner, JD, RAC
Regulatory Affairs Associates, Inc.
40701 Woodward Avenue, Suite 102
Bloomfield Hills, MI 48304 |
| | Phone: +1 (248) 712-0356
Fax: +1 (203) 413-4320
Email: 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
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).
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.
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
2
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.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 two main elements: the department's name encircling the image and a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of a human figure, with three curved lines forming the body and head.
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.
4
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,
Image /page/4/Picture/5 description: The image contains the text "Kwame O. Ulmer-s". The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-s" on the bottom line. The text is bold and black, and the background is white. The text is slightly distorted.
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 EF
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