(69 days)
K781151A, K943574
Not Found
No
The description focuses on the material properties of a dental impression material and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is an impression material used for taking impressions of teeth and oral tissue, which is a diagnostic or procedural aid, not a therapeutic treatment itself.
No
The device is an impression material used for taking impressions of teeth and/or oral tissue, which serves as a base for final impressions. Its function is to create a physical mold, not to diagnose a condition or disease.
No
The device is a physical impression material, not software. The description clearly details a two-component paste that hardens.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to take impressions of teeth and/or oral tissue for dental purposes. This is a physical process for creating a mold, not a diagnostic test performed on a sample from the body to detect diseases or conditions.
- Device Description: The description details the physical properties of the material used to create the impression. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing bodily fluids, tissues, or other samples for diagnostic purposes. The device is used directly in the mouth to create a physical impression.
IVD devices are used to perform tests in vitro (outside the body) on samples to provide information for diagnosis, monitoring, or screening. This device is used in vivo (in the body) to create a physical mold.
N/A
Intended Use / Indications for Use
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.
Product codes
ELW
Device Description
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is a very high viscosity, elastomeric impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL consists of two-components (base paste and catalyst paste) which harden to form a base for final impressions. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL with "smart wetting" improves both wetting on the tooth surface and model detail reproduction. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is designed to be used with Aquasil Regular Set Impression Materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth and/or oral tissue
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
The mixed product was tested by the Ames Mutagenicity Test, Acute Dermal Toxicity Test, and the Hamster Cheek Pouch Irritation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.
Key Metrics
Not Found
Predicate Device(s)
K781151A, K943574
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
510(k) SUMMARY
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DENTSPLY
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax 1717 854-2343
P. J. Lehn Telefax (717) 849-4343
| CONTACT: | P. Jeffery Lehn |
|---|---|
| DATE PREPARED: | September 19, 1997 |
| TRADE NAME: | AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL |
| CLASSIFICATION NAME: | Impression Material |
| PREDICATE DEVICE: | Reprosil® Putty Impression Material | K781151A |
|---|---|---|
| Aquasil Smart Wetting® Impression Material | K943574 |
DEVICE DESCRIPTION: AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is a very high viscosity, elastomeric impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL consists of two-components (base paste and catalyst paste) which harden to form a base for final impressions. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL with "smart wetting" improves both wetting on the tooth surface and model detail reproduction. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is designed to be used with Aquasil Regular Set Impression Materials.
INTENDED USE: AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.
TECHNOLOGICAL CHARACTERISTICS: All of the components of AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL have been used in DENTSPLY legally marketed predicate devices or found to be safe for dental use.
Due to the similarity of the formulation of AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL to the Aguasil Smart Wetting Impression Material, we believe that additional biocompatibility testing of the new impression material is unnecessary.
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 cytotoxicity. The mixed product was evaluated for dermal toxicity, for imitation, and for mutagenicity.
The base pastes give a moderate cytotoxicity and the catalyst pastes were noncylotoxic. When mixed, the cytotoxicity persisted, but was recorded as a lower value than the value for Reprosil® Impression Material.
1
510(k) SUMMARY (cont'd.)
TRADE NAME: AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL
The mixed product was tested by the Ames Mutagenicity Test, Acute Dermal Toxicity Test, and the Hamster Cheek Pouch Irritation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.
As an impression material, AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is in the mouth for less than ten minutes.
We believe that the prior use of the components in legally marketed, the similarity of formulation to the predicate devices, the results of 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 EASY MIX PUTTY IMPRESSION MATERIAL for the intended uses.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three overlapping profiles suggesting a sense of community or interconnectedness. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffrey Lehn Associate Director Corporate Compliance DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17404
DEC | | 1997
Re : K973781 Trade Name: Aquasil™ Easy Mix Putty Impression Material Requlatory Class: II Product Code: ELW Dated: September 19, 1997 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 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.
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Lehn
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(K) Number: ______________________________________________________________________________________________________________________________________________________________________________
AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL Device Name:
Indications for Use:
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________