(435 days)
No
The summary describes a dental impression material with properties related to setting time, dust reduction, and antimicrobial efficacy. There is no mention of any computational or analytical functions that would typically involve AI/ML.
No
JELTRATE PLUS is an impression material used for dental impressions, not a device intended to treat or cure a disease or condition. Its function is to create a mold of dental structures.
No
The device is described as an impression material used for routine dental impressions. While it aids in infection control, its primary function is to create a mold, not to diagnose a condition or disease. The summary of performance studies indicates its effectiveness in eliminating microorganisms on the impression itself, not diagnosing an issue in a patient.
No
The device description and intended use clearly indicate that JELTRATE PLUS is a physical impression material used for dental impressions, not a software product.
Based on the provided information, JELTRATE PLUS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for all routine dental impressions." This is a physical process of creating a mold of teeth and oral structures, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties of the material (dust free, fast setting) and its ability to reduce surface microorganisms on the impression itself. This is related to infection control during the impression process, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a biological sample (blood, urine, tissue, etc.) to diagnose a disease or condition. The "eliminates up to 99% of viable surface microorganisms" claim relates to the impression material's properties, not a diagnostic measurement of a patient's health.
- No Mention of Diagnostic Output: The device does not produce a diagnostic result or interpretation.
In summary, JELTRATE PLUS is a dental impression material used for creating physical molds, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
JELTRATE PLUS is used for all routine dental impressions.
Product codes
Not Found
Device Description
JELTRATE PLUS is dust free, fast setting, and helps protect staff from infection due to cross-contamination prior to soaking the impression.
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)
We believe the conclusions of the study conducted support the additional claim that JELTRATE PLUS eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% elimination of viable surface microorganisms after water rinsing the impression for just 15 seconds.
Predicate Device(s)
Jeltrate PLUS Impression Material K883842
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
st College Avenue 7405-0
AUG 1 3 1996
COMPLIANCE DEPT. TELEFAX (717) 849-4343
August 8, 1996
| | | 301-480-3002
TELEFAXED AND
EXPRESS MAIL | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mr. Greg Singleton (HFZ-480)
Food and Drug Administration
Center for Devices and Radiological Health
9200 Corporate Boulevard
Rockville, MD 20850 | | | FDA/CDRH
9 AUG 96 |
| AMENDMENT #3 | K952614, Jeltrate® PLUS™ Antimicrobial Dustless Alginate
Impression Material | | RECEIVED |
This letter is in response to your telephone call to me this afternoon.
As you requested, attached is a revised 510(K) SUMMARY for K952614, changing the claim to read:
Jeltrate® PLUS™ eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.
If you have any additional questions, please don't hesitate to contact me. Thank you.
Sincerely,
I. Jeffrey Lek
P. Jeffery Lehn Associate Director Corporate Compliance
Attachment
1
Image /page/1/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and closely spaced together. The overall impression is of a strong, established brand name. The image is in black and white.
DENTSPLY Internationa
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
(717) 845-7511
Fax (717) 854-2943
TELEFAX (717) 849-4343
510(k) SUMMARY
NAME & ADDRESS: DENTSPLY International, 570 West College Avenue, York, PA 17404 CONTACT: P. Jeffery Lehn (717) 849-4343 (717) 845-7511 FAX: PHONE : DATE PREPARED: August 8, 1996
TRADE OR PROPRIETARY NAME: JELTRATE® PLUS™ IMPRESSION MATERIAL
COMMON OR USUAL NAME: Impression Material
Impression Material, 21 CFR, 872.3660 CLASSIFICATION NAME:
LEGALLY MARKETED DEVICE: Jeltrate PLUS Impression Material K883842
DESCRIPTION OF DEVICE: JELTRATE PLUS is dust free, fast setting, and helps protect staff from infection due to cross-contamination prior to soaking the impression.
INTENDED USE: JELTRATE PLUS is used for all routine dental impressions.
TECHNOLOGICAL CHARACTERICS: There has been no change in composition, design, material, packaging, function or manufacture of Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material (K883842). This submission represents only an additional claim.
We believe the conclusions of the study conducted support the additional claim that JELTRATE PLUS eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.