(43 days)
Not-Found
Not Found
No
The device description and intended use clearly describe a dental material (sealant) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is a dental material used to seal pits and fissures in teeth, preventing decay rather than treating an existing disease or condition.
No
The device is described as a dental material for sealing pits and fissures, which is a treatment or preventive measure, not a diagnostic one.
No
The device description clearly states it is a "dental material" supplied as a "medium consistency paste," indicating it is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "seal the pits and fissures of teeth." This is a direct application to the patient's teeth for a therapeutic or preventative purpose.
- Device Description: The description confirms it's a "dental material" applied to teeth.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information. IVDs are used to perform tests on specimens taken from the human body.
This device is a dental sealant, which is a medical device used directly on the patient.
N/A
Intended Use / Indications for Use
Pulpdent Seal-Rite™UDMA is a radiopaque, fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Pulpdent Seal-Rite™ UDMA is a radiopaque, fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth. It contains no Bisphenol A. It is supplied as a medium consistency paste, which flows readily from cusp to cusp and is easily distinguishable from enamel. Pulpdent Seal-Rite™ UDMA cures completely after light curing for 20 seconds. Various formulations (with and without color, with and without fluoride) will be offered to allow for the clinician's discretion and preference in different situations. Pulpdent Seal-Rite" UDMA complies with ANSI/ADA Specification No. 39 for Pit and Fissure Sealants.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pulpdent Seal-Rite and Seal-Rite Low Viscosity, Vivodent/Ivoclar Helioseal and HelioSeal-F, Kulzer Estiseal, Ultradent Ultra-Blend
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
EXHIBIT 8
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262
Pulpdent Seal-Rite™ UDMA DEVICE NAME:
PREDICATE DEVICE:
Pulpdent Seal-Rite and Seal-Rite Low Viscosity Vivodent/Ivoclar Helioseal and HelioSeal-F Kulzer Estiseal Ultradent Ultra-Blend
Pulpdent Seal-Rite™UDMA is a radiopaque, DESCRIPTION AND INTENDED USE: fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth. It contains no Bisphenol A. It is supplied as a medium consistency paste, which flows readily from cusp to cusp and is easily distinguishable from enamel. Pulpdent Seal-Rite™ UDMA cures completely after light curing for 20 seconds. Various formulations (with and without color, with and without fluoride) will be offered to allow for the clinician's discretion and preference in different situations. Pulpdent Seal-Rite" UDMA complies with ANSI/ADA Specification No. 39 for Pit and Fissure Sealants.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent Seal-Rite™ UDMA is substantially equivalent in composition and/or intended use to the above mentioned predicate products. Please see EXHIBIT 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio... both composites and glass ionomers are relatively trouble free. There is no evidence of short or long term risk... there is no suspicion of any problems after literally billions of procedures in the United States." Please see EXHIBIT 6 for the complete papers from the conference.