(75 days)
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No
The 510(k) summary describes a dental cement and does not mention any AI or ML capabilities.
No
This device is a dental cement, used for permanent cementation in dental procedures. While it's used in a medical context, it's not designed to treat a disease or condition itself, but rather to affix restorations.
No
The device is described as a resin cement for permanent cementation in dentistry, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "radiopaque, resin cement" supplied as a "two-paste system" or "single light-cured paste," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the permanent cementation of dental restorations and procedures within the mouth (in vivo).
- Device Description: The description details a resin cement used for bonding materials in the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples outside the body (in vitro) for diagnostic purposes. IVDs typically involve analyzing biological samples like blood, urine, or tissue to detect diseases or conditions.
This device is a dental material used for restorative and prosthetic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Pulpdent ResiLute IITM is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
It is supplied as a chemical-cure or dual-cure two-paste system (base and catalyst), with and without fluoride, that mixes easily, and as a single light-cured paste, also with and without fluoride. Pulpdent ResiLute II™ has a very low film thickness and bonds to enamel, dentin, metals and ceramic. Pulpdent ResiLute INM conforms to ADA Specification No. 27 for Direct Filling Resins (see EXHIBIT 7); when a specification is adopted for resin cements, Pulpdent ResiLute IITM will conform to it.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 HardCore Pulpdent Resin Cement, Pulpdent ResiLute, Septodent RESIMENT, Bisco All Bond C & B Luting Cement, Cosmedent Insure, Kerr Porcelite / Porcelite Dual Cure, Bisco Choice Porcelain Veneer System
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.
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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).
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
3 1996 성금융
Pulpdent ResiLute II™
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 (617) 926-6262 FAX:
Pulpdent ResiLute II™ DEVICE NAME:
PREDICATE DEVICE:
Pulpdent HardCore Pulpdent Resin Cement Pulpdent ResiLute Septodent RESIMENT Bisco All Bond C & B Luting Cement Cosmedent Insure Kerr Porcelite / Porcelite Dual Cure Bisco Choice Porcelain Veneer System
DESCRIPTION AND INTENDED USE: Pulpdent ResiLute IITM is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques. It is supplied as a chemical-cure or dual-cure two-paste system (base and catalyst), with and without fluoride, that mixes easily, and as a single light-cured paste, also with and without fluoride. Pulpdent ResiLute II™ has a very low film thickness and bonds to enamel, dentin, metals and ceramic. Pulpdent ResiLute INM conforms to ADA Specification No. 27 for Direct Filling Resins (see EXHIBIT 7); when a specification is adopted for resin cements, Pulpdent ResiLute IITM will conform to it.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent ResiLute IITM is substantially equivalent in composition and 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.