(89 days)
Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
This document outlines the substantial equivalence of the "Elements™" dental impression material to a predicate device, "Take 1 (K091613)", based on non-clinical performance testing. It does not describe a study involving an AI-powered medical device or human readers. Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.
The provided text focuses on the following:
- Device: Elements™ (dental impression material)
- Predicate Device: Take 1 (K091613)
- Purpose: To demonstrate substantial equivalence for FDA 510(k) clearance.
- Study Type: Non-clinical performance testing based on ISO 4823-2000.
- Key Finding: "No clinical testing was performed."
Since the request is about an "AI device" and "how much human readers improve with AI vs without AI assistance," the provided document is irrelevant to answering those specific questions. The document details the physical properties and a comparison of a traditional dental material, not an AI or software as a medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 21038 Commerce Point Drive Walnut, CA 91789
Re: K151150
Trade/Device Name: ElementsTM Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: April 24, 2015 Received: April 30, 2015
Dear Ms. Zhu:
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. Isting 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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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/ResourcesforYou/Industry/default.htm.
Sincerely yours. lina Kiana -S
for Erin I. Keith, M.S. 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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Image /page/2/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, sans-serif font, with a curved line underneath. Below "PacDent" is the text "International, Inc." and "passion for excellence..." in a smaller font.
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section III
Indications for Use Statement
510(k) Number (if known): _K151150
Device Name: __ Elements™
Indications for Use:
Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
Prescription Use _________________
OR
Over-The-Counter Use
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Image /page/3/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a stylized swoosh underneath. Below that, in a smaller font, it says "International, Inc." and "passion for excellence..."
Pac-Dent International, Inc.
21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section IV
510(k) Summary
Submitter:
Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821
Contact Person:
Wenying Zhu Materials Engineer 909-839-0888 ext.111
Date Summary Prepared:
July 2015
Device Name Trade Name: Elements™ Common Name: Dental Impression Material Device Classification: Class II Classification Product Code: ELW Classification Name: Material, Impression, per 21 CFR 872.3660
Predicate Device
Take 1 (K091613)
Description of Device
Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
Indications for Use
Elements™ is intended for use with all crown and bridge, occlusal and implant impression
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Image /page/4/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a white swoosh underlining the text. Below "PacDent" is the text "International, Inc." and the phrase "passion for excellence..."
Pac-Dent International, Inc.
21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
techniques to reproduce the structure of a patient's teeth and gums.
Summarv of Biocompatibilitv Tests
The biocompatibility of Elements™ was found to be substantially equivalent to the predicate based on a risk assessment done per ISO 10993-1 and the identification of legally marketed predicate devices for all ingredients in the chemical composition.
| DescriptiveInformation | Subject Device | Predicate Device | Summary |
|---|---|---|---|
| Indications forUse | Elements ™ | Take 1 (K091613) | |
| Elements™ is intended for usewith all crown and bridge,occlusal and implantimpression techniques toreproduce the structure of apatient's teeth and gums. | Take 1 is an addition-cure vinlypolysiloxane dental impressionmaterial that is used for all crownand bridge, edentulous, orthodonticand implant impression techniques. | The indications foruse of the subjectand predicatedevices is toreproduce thestructure of apatient's teeth andgums, including butnot limited to theapplications listed inthe indications foruse. | |
| Composition ofMaterials | Vinly polysiloxaneFillerPigments | Vinly polysiloxaneFillerPigments | The composition ofthe subjective andpredicate devicesare the same |
| Mode of Use | 1. Light body (Type 3)A low viscosity impressionmaterial used to captureextraordinary subgingivaldetails.2. Regular body/Monophase(Type 2)A medium viscosity | 1. Take 1 Light body/Regular bodywash:A very hydrophilic impressionmaterial used in heavy/wash orputty/wash impression proceduresand capable of capturingextraordinary subgingival details. Itis used in crown and bridge and all | The nomenclature isdifferent betweenthe subjective andpredicate devices.According to thedescription andbench test result,subjective device's |
Comparison of Technological Characteristics
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Image /page/5/Picture/0 description: The image shows the logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a large, bold, black font, with a white swoosh underneath. Below that, in a smaller font, are the words "International, Inc." and "passion for excellence..."
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut ▪ California ▪ 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
| monophase impressionmaterial used in single stepimpression procedures.3. Heavy body (Type 1)A heavy body impressionmaterial used as base intwo-step heavy-washapplications. | high precision applications.2. Take 1 Medium body:A medium viscosity monophaseimpression material with superiormechanical strength used in singlestep impression procedures suchas mouth guards, night guards,orthodontic, and edentulousapplications.3. Take 1 Tray (heavy body)A heavy body impression materialcombining strength, elasticity anddimensional stability to deliver themost accurate impressions. It isused in two-step heavy-washapplications such as for crown andbridge procedures. | light body iscomparable topredicate device'slight body/regularbody wash, regularbody/monophase iscomparable tomedium body andheavy body iscomparable to tray.The classification ofthe subjectivedevice is alsocomplied with ISO4823-2000 (Type 1-Type 3). | |
|---|---|---|---|
| FDA-RecognizedStandards | ISO 4823-2000 | ISO 4823-2000 | Claims are thesame |
Comparison of physical properties
| ElementsTM | Take 1 (K091613) | |||||
|---|---|---|---|---|---|---|
| Test MethodISO 4823-2000 | Heavybody | Regularbody/Monophase | Light body | Tray(heavybody) | Mediumbody | Lightbody/Regularbody wash |
| Detail Reproduction | PASS | PASS | PASS | PASS | PASS | PASS |
| Linear Dimensional | 0.14% | 0.05% (0.02) | 0.08% | 0.03% | 0.07% | 0.07% (0.01) |
| Change | (0.01) | (0.02) | (0.01) | (0.01) | ||
| Compatibility withGypsum | PASS | PASS | PASS | PASS | PASS | PASS |
| Elastic Recovery | 99.7 (0.1) | 99.6 (0.3) | 99.8 (0.1) | 99.45 (0.1) | 99.65 (0.1) | 99.84 (0.1) |
| Strain-In-Compression | 2.85 (0.1) | 3.67 (0.13) | 4.93 (0.1) | 2.92 (0.25) | 3.4 (0.15) | 5.4 (0.15) |
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Image /page/6/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a registered trademark symbol next to it. Below that, the words "International, Inc." are in a smaller, lighter font, and below that, the words "passion for excellence..." are in a similar font.
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Substantial Equivalence
In summary, this submission demonstrates that Elements™ is substantially equivalent to the identified predicated product for its intended use and technological characteristics. Non clinical performance testing per ISO 4823-2000 substantiates equivalence in terms of detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery and strain in compression.
No clinical testing was performed.
§ 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).