(89 days)
Not Found
No
The device description and performance studies focus on the physical properties of a dental impression material, with no mention of AI or ML.
No
The device is a dental impression material used to reproduce the structure of teeth and gums, not to treat a condition or disease.
No
Explanation: The device is described as a dental impression material used to reproduce the structure of teeth and gums. This process is for creating molds, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "polyvinylsiloxane dental impression material," which is a physical material, not software. The performance studies also focus on material properties.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reproduce the structure of a patient's teeth and gums" for crown and bridge, occlusal, and implant impression techniques. This is a physical process of creating a mold of anatomical structures.
- Device Description: It's a dental impression material (polyvinylsiloxane). This is a material used to physically capture the shape of teeth and gums.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens. It's used directly on the patient's anatomy to create a physical impression.
The information provided clearly describes a dental material used for creating physical impressions, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ElementsTM 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.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
ElementsTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's 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)
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.
Comparison of physical properties showed:
Detail Reproduction: PASS for all ElementsTM types (Heavy body, Regular body/Monophase, Light body).
Linear Dimensional Change: 0.14% (0.01) for Heavy body, 0.05% (0.02) for Regular body/Monophase, 0.08% (0.02) for Light body.
Compatibility with Gypsum: PASS for all ElementsTM types.
Elastic Recovery: 99.7 (0.1) for Heavy body, 99.6 (0.3) for Regular body/Monophase, 99.8 (0.1) for Light body.
Strain-In-Compression: 2.85 (0.1) for Heavy body, 3.67 (0.13) for Regular body/Monophase, 4.93 (0.1) for Light body.
No clinical testing was performed.
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.
Take 1 (K091613)
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus with three intertwined snakes and three human profiles facing right. 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 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.
1
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
3
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
4
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.
| Descriptive
| Information | Subject Device | Predicate Device | Summary |
|---|---|---|---|
| Indications for | |||
| Use | Elements ™ | Take 1 (K091613) | |
| 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. | Take 1 is an addition-cure vinly | ||
| polysiloxane dental impression | |||
| material that is used for all crown | |||
| and bridge, edentulous, orthodontic | |||
| and implant impression techniques. | The indications for | ||
| use of the subject | |||
| and predicate | |||
| devices is to | |||
| reproduce the | |||
| structure of a | |||
| patient's teeth and | |||
| gums, including but | |||
| not limited to the | |||
| applications listed in | |||
| the indications for | |||
| use. | |||
| Composition of | |||
| Materials | Vinly polysiloxane | ||
| Filler | |||
| Pigments | Vinly polysiloxane | ||
| Filler | |||
| Pigments | The composition of | ||
| the subjective and | |||
| predicate devices | |||
| are the same | |||
| Mode of Use | 1. Light body (Type 3) | ||
| A low viscosity impression | |||
| material used to capture | |||
| extraordinary subgingival | |||
| details. |
- Regular body/Monophase
(Type 2)
A medium viscosity | 1. Take 1 Light body/Regular body
wash:
A very hydrophilic impression
material used in heavy/wash or
putty/wash impression procedures
and capable of capturing
extraordinary subgingival details. It
is used in crown and bridge and all | The nomenclature is
different between
the subjective and
predicate devices.
According to the
description and
bench test result,
subjective device's |
Comparison of Technological Characteristics
5
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 impression
material used in single step
impression procedures.
3. Heavy body (Type 1)
A heavy body impression
material used as base in
two-step heavy-wash
applications. | high precision applications.
2. Take 1 Medium body:
A medium viscosity monophase
impression material with superior
mechanical strength used in single
step impression procedures such
as mouth guards, night guards,
orthodontic, and edentulous
applications.
3. Take 1 Tray (heavy body)
A heavy body impression material
combining strength, elasticity and
dimensional stability to deliver the
most accurate impressions. It is
used in two-step heavy-wash
applications such as for crown and
bridge procedures. | light body is
comparable to
predicate device's
light body/regular
body wash, regular
body/monophase is
comparable to
medium body and
heavy body is
comparable to tray.
The classification of
the subjective
device is also
complied with ISO
4823-2000 (Type 1-
Type 3). |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA-Recognized
Standards | ISO 4823-2000 | ISO 4823-2000 | Claims are the
same |
Comparison of physical properties
| ElementsTM | Take 1 (K091613) | |||||
|---|---|---|---|---|---|---|
| Test Method | ||||||
| ISO 4823-2000 | Heavy | |||||
| body | Regular | |||||
| body/Monop | ||||||
| hase | Light body | Tray | ||||
| (heavy | ||||||
| body) | Medium | |||||
| body | Light | |||||
| body/Regular | ||||||
| body 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 with | ||||||
| Gypsum | 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) |
6
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.