(50 days)
K943574, K781151A
No
The summary describes a traditional impression material and does not mention any computational or data-driven processes indicative of AI/ML. The term "SMART WETTING" refers to the material's hydrophilic properties, not AI.
No
This device is an impression material used to record anatomical details, not to treat or alleviate a medical condition.
No
Explanation: The device is described as an impression material used to record details of the oral cavity for making impressions or duplicating models, not for diagnosing diseases or conditions.
No
The device is a physical impression material, a two-part vinylpolysiloxane, used to record details of the oral cavity. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create impressions of the oral cavity for dental purposes (crown and bridge impressions, model duplication). This is a physical process for capturing anatomical details, not a diagnostic test performed on biological samples.
- Device Description: The description details a material used to physically record the shape of oral structures. It doesn't mention any components or processes related to analyzing biological samples for diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
The device is a dental impression material, which is a medical device used in the practice of dentistry, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.
AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV Fast Set Impression Material in a dual phase impression Technique, capturing one or two adjacent preparations. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.
Product codes
Not Found
Device Description
AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is a two-part (base/catalyst) hydrophilic vinylpolysiloxane (VPS), crown and bridge impression material used to record the details of hard and soft surfaces of the oral cavity.
AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. These elastomeric impression materials have excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.
AQUASIL™ RIGID Regular Set and Fast Set IMPRESSION MATERIALs improve both wetting on the tooth surface and model detail reproduction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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)
The catalyst and base pastes and the mixed product were evaluated for cytotoxicity. The mixed product was evaluated for dermal toxicity, for irritation, and for mutagenicity.
The base pastes give a moderate cytotoxicity and the catalyst pastes were non-cytotoxic. 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 Irritation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K781151A
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
K970Ø433
510(k) SUMMARY
Page 1 of 2
DENTSPLY
NAME & ADDRESS :
MAR 2 7 1997
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn February 3, 1997 DATE PREPARED: CONTACT :
AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL TRADE NAME :
Impression Material CLASSIFICATION NAME:
AquaSil™ Smart Wetting Impression Material K943574 PREDICATE DEVICE:
DEVICE DESCRIPTION: AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is a two-part (base/catalyst) hydrophilic vinylpolysiloxane (VPS), crown and bridge impression material used to record the details of hard and soft surfaces of the oral cavity.
AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. These elastomeric impression materials have excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.
AQUASIL™ RIGID SMART WETTING Regular Set and Fast Set IMPRESSION MATERIALs improve both wetting on the tooth surface and model detail reproduction.
INTENDED USE: AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.
AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV Fast Set Impression Material in a dual phase impression Technique, capturing one or two adjacent preparations. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.
TECHNOLOGICAL CHARACTERISTICS: All of the components of AQUASIL® RIGID SMART WETTING IMPRESSION MATERIAL have been used in DENTSPLY predicate The one component not found in the predicate device (K943574) devices. has been used in DENTSPLY's legally marketed Reprosil® Impression Material (K781151A) .
1
510(k) SUMMARY (cont'd.)
ﺐ ﺗ
TRADE NAME: AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL
Due to the similarity of the formulation of AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL to the AquaSil™ Smart Wetting Heavy Body Impression Material, we believe that additional biocompatibility testing of the new impression material is unnecessary.
The predicate device, AquaSil® Smart Wetting Impression Material, was evaluated in K943574, as outlined below:
The catalyst and base pastes and the mixed product were evaluated for cytotoxicity. The mixed product was evaluated for dermal toxicity, for irritation, and for mutagenicity.
The base pastes give a moderate cytotoxicity and the catalyst pastes were non-cytotoxic. 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 Irritation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.
As crown and bridge impression materials, AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL and the predicate device (K943574) are in the mouth for, at most, ten minutes.
We believe that the prior use of the components in predicate medical 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™ RIGID SMART WETTING IMPRESSION MATERIAL for the intended use.
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