(34 days)
Not Found
No
The device description and intended use are focused on a chemical solution for surface preparation, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device is described as a "preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures" and acts to reduce surface tension. It does not directly treat a disease or condition.
No
The device is described as a "preparation conditioning solution" used prior to impression procedures to improve surface wetting. Its function is to facilitate the impression-taking process, not to diagnose a medical condition or disease.
No
The device description clearly states it is a "solution," which is a chemical substance, not software. It is applied to physical substrates.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prepare and condition surfaces prior to taking an impression. This is a preparatory step for a dental procedure, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties of the solution (surface wetting, reduced surface tension, reduced contact angle) and its application to various surfaces in the mouth. It does not describe any analysis of biological samples or the detection of specific substances or conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a material used in vivo (within the body, specifically the mouth) to facilitate a dental procedure (taking an impression). This aligns with the definition of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PRE-IMPRESSION CONDITIONING SOLUTION is indicated as a preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures.
Indications for Use: Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures
Product codes
ELW and MVL
Device Description
The PRE-IMPRESSION CONDITIONING Solution is a product to be used in the impressiontaking process. When applied to substrates such as sulcular tissue; tooth preparations; ceramic, composite, or metal core build-up material; or implant abutments or copings, it provides a uniform surface condition with reduced surface tension prior to the application of an elastomeric impression material. This standardized surface with reduced contact angle on all impressed substrates allows capture of fine preparation detail both supra and subgingiyally.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sulcular tissue; tooth preparations; ceramic, composite, or metal core build-up material; or implant abutments or copings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023776, K983966, K940685, K973781
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
JUN 2 6 2006
.NAME & ADDRESS:
్రాలు
మూలాలు
DENTSPLY International World Headquarters Susquehanna Commerce Ctr. 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) (717) 849-4762 (fax) www.dentsply.com
K-3
Helen Lewis
CONTACT:
DATE PREPARED:
May 17, 2006
TRADE OR PROPRIETARY NAME:
PRE-IMPRESSION CONDITIONING SOLUTION
CLASSIFICATION NAME:
Impression material, 872.3660
PREDICATE DEVICES:
Xeno® III Dental Adhesive, K023776 Nupro® Prophylaxis Paste, K983966 Pretreatment Solution, K940685 Aquasil Easy Mix Putty Impression Material. K973781
DEVICE DESCRIPTION:
The PRE-IMPRESSION CONDITIONING Solution is a product to be used in the impressiontaking process. When applied to substrates such as sulcular tissue; tooth preparations; ceramic, composite, or metal core build-up material; or implant abutments or copings, it provides a uniform surface condition with reduced surface tension prior to the application of an elastomeric impression material. This standardized surface with reduced contact angle on all impressed substrates allows capture of fine preparation detail both supra and subgingiyally.
INTENDED USE:
The PRE-IMPRESSION CONDITIONING SOLUTION is indicated as a preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in PRE-IMPRESSION CONDITIONING SOLUTION have been used in legally marketed devices and are safe for dental use. We believe that the prior use of the components of PRE-IMPRESSION CONDITIONING SOLUTION in legally marketed devices and the data provided, support the safety and effectiveness of PRE-IMPRESSION CONDITIONING SOLUTION for the indicated use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 6 2006
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K061427
Trade/Device Name: Pre-Impression Conditioning Solution Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW and MVL Dated: May 17, 2006 Received: May 23, 2006
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 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 (PMA). it may be subject to such 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.
2
Page 2 - Ms. Helen 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 requiremants 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 Paris (201): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product railition control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gal/y 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
K061427
Device Name: PRE-IMPRESSION CONDITIONING SOLUTION
Indications for Use:
Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sudor Runa
esiology, General Hospital.
K0611727