(62 days)
Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models.
Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material.
Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.
AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is an extra low viscosity. elastomeric impression material with excellent hydrophilic properties, dimensional accuracy. high tear strength, and resistance to permanent deformation. AQUASIL XLV IMPRESSION MATERIAL with "smart wetting" improves wetting both the tooth surface and the model detail reproduction.
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. It is available in cartridge delivery. In developing the Regular Set and Fast Set, adjustments were made to the active ingredients as compared to the predicate device (K943574). These adjustments were made to obtain two speeds of the material with improved physical properties. The speed of the materials was adjusted by increasing the amounts of catalyst and retarder fluids over the predicate device. These changes improved the setting properties of the mixed impression material and allowed for two speeds of the same viscosity of impression material. Other changes were made to improve the flow property of the mixed impression material and the shelf stability of the product.
AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is a twopart (base/catalyst) hydrophilic viny|polysiloxane (VPS), impression material used to record the details of hard and soft surfaces of the oral cavity.
This 510(k) submission for the AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL does not contain information about acceptance criteria or a study that directly proves the device meets specific performance metrics in comparison to a predicate device, as one would typically expect for a medical device.
Instead, the submission focuses heavily on substantial equivalence to the predicate device (Aquasil™ Smart Wetting Impression Material, K943574) based on:
- Similarity of formulation: All components of the new device have been used in legally marketed DENTSPLY devices.
- Minor adjustments leading to improved physical properties: "adjustments were made to the active ingredients as compared to the predicate device (K943574). These adjustments were made to obtain two speeds of the material with improved physical properties. The speed of the materials was adjusted by increasing the amounts of catalyst and retarder fluids over the predicate device. These changes improved the setting properties of the mixed impression material and allowed for two speeds of the same viscosity of impression material. Other changes were made to improve the flow property of the mixed impression material and the shelf stability of the product."
- Prior biocompatibility testing of the predicate device: The submission states, "Due to the similarity of the formulation of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL to the predicate device (K943574), we believe that additional biocompatibility testing of the new impression material is unnecessary." It then refers to biocompatibility test results for the predicate device (K943574), which found it to be non-mutagenic, non-toxic, and a non-irritant.
- Limited exposure time in the mouth (less than ten minutes).
Therefore, I cannot provide the requested table or describe a 'study that proves the device meets the acceptance criteria' in the traditional sense of performance metrics against specific acceptance thresholds for this specific device. The "performance data" referred to is primarily the biocompatibility of the predicate device, which is inferred to apply to the new device due to formulation similarity, and general statements about improved physical properties.
Here's what information can be extracted/inferred based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria for performance (e.g., detail reproduction, dimensional accuracy) are stated for the AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL in this document. The performance information provided is related to biocompatibility, inferred from the predicate device.
| Performance Metric (Biocompatibility - inferred from predicate) | Acceptance Criteria (inferred from predicate testing) | Reported Device Performance (for predicate, applied to new device) |
|---|---|---|
| Cytotoxicity | Acceptable level of cytotoxicity | Base pastes: Moderate cytotoxicity. Catalyst pastes: Non-cytotoxic. Mixed product: Cytotoxicity persisted, but lower than Reprosil® Impression Material. |
| Mutagenicity (Ames Test) | Non-mutagenic | Non-mutagenic |
| Acute Dermal Toxicity | Non-toxic | Non-toxic |
| Irritation (Hamster Cheek Pouch Study) | Non-irritant | Non-irritant |
| Detail Reproduction, Dimensional Stability, Tear Strength | Not explicitly stated in this document | Device described as having "excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation." However, no specific quantitative values or acceptance criteria are given, nor is a study comparing these to the predicate's performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any performance testing of the AQUASIL™ XLV XLV SMART WETTING IMPRESSION MATERIAL. The biocompatibility tests referenced are for the predicate device, and their sample sizes are not provided in this document.
- Data Provenance: The biocompatibility tests were likely conducted by DENTSPLY or a contracted lab. The country of origin of the data is not specified. The tests are retrospective in relation to this 510(k) submission, as they were conducted on the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This document describes a 510(k) submission based on substantial equivalence and biocompatibility testing (of a predicate), not a study involving experts to establish ground truth for performance metrics.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method is mentioned as there's no clinical study or expert review panel described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The device is an impression material, not an imaging or diagnostic device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical impression material, not an algorithm or software.
7. Type of Ground Truth Used
- For biocompatibility: Laboratory test results (e.g., cell culture for cytotoxicity, animal models for toxicity/irritation) serve as the "ground truth" for assessing biological safety. This is based on established scientific protocols.
- For physical properties (e.g., dimensional accuracy, tear strength, flow): While the device is described as having these improved properties, no specific studies or quantitative ground truth measurements are provided in this document to support these claims for the XLV version compared to its predicate. The "improvements" are mentioned as being achieved through "adjustments... to obtain two speeds of the material with improved physical properties."
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
{0}------------------------------------------------
510(k) SUMMARY DEC - 4 1997 Page 1 of 2
Image /page/0/Picture/17 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word appears to be a logo or brand name.
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax 1777 054-2343
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn DATE PREPARED: October 2, 1997
AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL TRADE NAME:
CLASSIFICATION NAME: Impression Material
PREDICATE DEVICE: Aquasil™ Smart Wetting Impression Material K943574
DEVICE DESCRIPTION: AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is an extra low viscosity. elastomeric impression material with excellent hydrophilic properties, dimensional accuracy. high tear strength, and resistance to permanent deformation. AQUASIL XLV IMPRESSION MATERIAL with "smart wetting" improves wetting both the tooth surface and the model detail reproduction.
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. It is available in cartridge delivery. In developing the Regular Set and Fast Set, adjustments were made to the active ingredients as compared to the predicate device (K943574). These adjustments were made to obtain two speeds of the material with improved physical properties. The speed of the materials was adjusted by increasing the amounts of catalyst and retarder fluids over the predicate device. These changes improved the setting properties of the mixed impression material and allowed for two speeds of the same viscosity of impression material. Other changes were made to improve the flow property of the mixed impression material and the shelf stability of the product.
INTENDED USE: AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is a twopart (base/catalyst) hydrophilic viny|polysiloxane (VPS), impression material used to record the details of hard and soft surfaces of the oral cavity.
Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models.
Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material.
Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.
{1}------------------------------------------------
TRADE NAME: AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL
TECHNOLOGICAL CHARACTERISTICS: All of the components of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL have been used in DENTSPLY legally marketed devices.
Due to the similarity of the formulation of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL to the predicate device (K943574), we believe that additional biocompatibility testing of the new impression material is unnecessary.
The predicate device. Aquasil Smart Wetting Impression Material, was evaluated and the reports can be found in K943574:
The catalyst and base pastes and the mixed product were evaluated for cytoxicity. The mixed product was evaluated for dermal toxicity, for initation, and for mutagenicity.
The base pastes give a moderate cytotoxicity and the catalyst pastes were noncytotoxic. When mixed, the cytotoxicity persisted, but was recorded as a lower value than the value for Reprosil® Impression Material.
The mixed product was tested by the Ames Mutagenicity Test. Acute Dermal Toxicity Test, and the Hamster Cheek Pouch Imitation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.
As impression materials, AQUASIL XLV SMART WETTING IMPRESSION MATERIAL and the predicate device (K943574) are in the mouth for less than ten minutes.
We believe that the prior use of the components in DENTSPLY legally marketed devices, the similarity of formulation to the predicate device, the final product testing of the predicate device, the limited exposure time in the mouth, and the performance data outlined above support the safety and effectiveness of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL for the intended uses.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
K973782 Re : Aquasil XLV Smart Wetting Impression Trade Name: Material II Requlatory Class: Product Code: ELW October 2, 1997 Dated: Received: October 3, 1997
Dear Mr. Lehn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
{3}------------------------------------------------
Page 2 - Mr. Lehn
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic childuli 312 or on notrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
{4}------------------------------------------------
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| 510(K) Number: | K973782 |
|---|---|
| ---------------- | --------- |
Device Name: AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL
Indications for Use:
Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models.
Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material.
Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✔
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Snover
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
000007
§ 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).