(87 days)
No
The device description and performance studies focus on the material composition and physical properties of a dental impression material, with no mention of AI or ML.
No
The device is an impression material used for dental impressions, which is a diagnostic or procedural material, not a therapeutic device.
No
This device is an impression material used to create dental impressions, not to diagnose a condition. It is used in all dental impression techniques.
No
The device description clearly states it is a "two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "all dental impression techniques." This is a physical process of creating a mold of teeth and surrounding tissues.
- Device Description: The description details a "two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material." This describes a material used for physical molding, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples. This device is a material used to create a physical impression for dental purposes.
N/A
Intended Use / Indications for Use
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.
Product codes
ELW
Device Description
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material suitable for all dental impression techniques where a light body (wash) and/or medium/heavy body (tray) material would be desired by the operator. Aquasil Ultra Smart Wetting Impression Material is available in light-bodied, medium-bodied or heavy-bodied consistencies; and fast set. regular set or extended work time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Data:
Toxicological Testing: All of the components used in the subject impression materials have been used in the devices as cleared in premarket notifications K021413, and K021416. There are no changes to the material composition of the subject impression materials proposed in this premarket notification.
Physical Properties: The purpose of this premarket notification is the addition of a contraindication; clarification of warnings and precautions; and clarification of the Indications for Use of the existing AQUASIL ULTRA SMART WETTING MATERIALS previously cleared in premarket notifications K021410, K021413, and K021416. There are no changes affecting the fundamental technology and chemical composition of the subject materials. There are minor quantitative changes to the existing ingredients in the material composition, but these changes do not affect the physical characteristics and mechanical properties of the materials.
Clinical Performance Data: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Suite 60W
DENTSPLY International World Headquarters
York, PA 17405-0872 18001 877-0020
Fax (717) 849-4343 www.dentsply.com
Susquehanna Commerce Center 221 West Philadelphia Street
SECTION 5. 510(k) SUMMARY for Title of Submission
Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
November 11, 2011 Date Prepared:
2. Device Name:
- Proprietary Name: .
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
Material, Impression 872.3660
-
CFR Number: Device Class:
Classification Name: -
[] . ELW Product Code: .
Predicate Device: 3.
.
.
DENTSPLY International's:
- . K021410- Aquasil Ultra XLV Smart Wetting Impression Material .
- K021413- Aquasil Ultra Rigid Smart Wetting Impression Material .
- K021416- Aquasil Ultra Monophase, Heavy and LV Smart Wetting Impression . Material .
4. Description of Device:
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material suitable for all dental impression techniques where a light body (wash) and/or medium/heavy body (tray) material would be desired by the operator. Aquasil Ultra Smart Wetting Impression Material is available in light-bodied, medium-bodied or heavy-bodied consistencies; and fast set. regular set or extended work time.
- న్. Indications for Use:
Aquasil Ultra Smart Wetting Impression Material is indicated for all dental impression techniques.
1
Description of Safety and Substantial Equivalence: 6.
Technological Characteristics
There are no changes proposed in this premarket notification which affect the fundamental technological characteristics of the subject devices. The intent of this premarket notification is: 1). The addition of the contraindication. "Aquasil Ultra Impression Material is contraindicated for use with patients who have a history of severe allergic reaction to peppermint oil or any of the components": 2). Clarification of warnings and precautions through the addition of warning against the use of the devices as a temporary reliner as well as a precaution their use with polvether. polysulfide, or condensation silicone materials; 3). Consolidation of Indications for Use; and 4). Documentation of minor quantitative changes to the existing ingredients in the composition of the AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL. AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL, and AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL cleared in premarket notifications K021410, K021413, and K021416, respectively. The changes described do not affect the substantial equivalence of the devices as originally cleared in premarket notifications K021410, K021413, and K021416.
Non-Clinical Performance Data.
Toxicological Testing
All of the components used in the subject impression materials have been used in the devices as cleared in premarket notifications K021413, and K021416. There are no changes to the material composition of the subject impression materials proposed in this premarket notification.
Physical Properties
The purpose of this premarket notification is the addition of a contraindication; clarification of warnings and precautions; and clarification of the Indications for Use of the existing AOUASIL ULTRA SMART WETTING MATERIALS previously cleared in premarket notifications K021410, K021413, and K021416. There are no changes affecting the fundamental technology and chemical composition of the subject materials. There are minor quantitative changes to the existing ingredients in the material composition, but these changes do not affect the physical characteristics and mechanical properties of the materials.
Clinical Performance Data. Not applicable.
Conclusion as to Substantial Equivalence
AQUASIL ULTRA XLV, LV, MONOPHASE, HEAVY, RIGID, XTRA WASH and XTRA TRAY SMART WETTING IMPRESSION MATERIAL are substantially equivalent to the currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
FEB 1 3 2012
Re: K113406
Trade/Device Names: Aquasil Ultra Smart Wetting Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 11, 2011 Received: November 18, 2011
Dear Ms. Lewis:
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 approval approvisions 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 If your device is chasilited (so itional 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.
3
Page 2 - Ms. Lewis
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 (reporting of inements 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.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/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 1 ou may 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 vours.
Wh 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
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SECTION 4. INDICATIONS FOR USE STATEMENT
113406
510(k) Number (if known):
Device Name: AQUASIL ULTRA SMART WETTNG IMPRESSION MATERIAL
Indications for Use:
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swen Rumpis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
113406
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DENTSPLY International