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PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass lonomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ Paste / Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

This document (K030036) is a 510(k) premarket notification for a dental device, Pulpdent Triple-Cure™ Paste/Paste Resin Reinforced Glass Ionomer Cement. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of typical AI/medical device performance evaluation.

Here's why and what information is available:

• Type of Device: This is a physical dental cement, not an AI/software as a medical device (SaMD). The evaluation process for physical materials like dental cements focuses on material properties, biocompatibility, and substantial equivalence to existing products.
• Regulatory Pathway: The 510(k) pathway (Premarket Notification) is used for devices that are substantially equivalent to existing legally marketed devices. This means the primary evidence required is a comparison to predicates, not a de novo study with acceptance criteria for novel performance.
• "Safety and Effectiveness" Section: The document references the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, which states: "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-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." This is a general statement about the class of materials, not specific acceptance criteria or performance metrics for this particular device. It's used to support the overall safety of the material type.

Based on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study to prove they are met because such a study, with specific acceptance criteria and performance metrics (like sensitivity, specificity, etc.), is not part of this 510(k) submission.

However, I can extract the relevant information about the device and its regulatory context:

Device Information:

• Trade Name: PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement
• Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin
• FDA Product Code: DYH, 21 CFR Part 872.3750 (also EMA listed later in the letter)
• Intended Use: Used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations, and as a base and liner under restorations. It's a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form.
• Not Recommended for: Post cementation or veneer cementation.
• Predicate Devices:
  • Pulpdent Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement (This appears to be an earlier version or related product by the same company)
  • GC Fuji Ortho LC (light-cure)
  • GC Fuji Ortho Self-cure
  • Pulpdent Band-Rite

The core of this submission is the "Comparison with Predicate Products," which states: "PULPDENT Triple Cure Paste / Paste is substantially equivalent in composition and intended use to the predicate products listed above. Please see Exhibit 4 for the entire comparison." (Exhibit 4 is not provided in the input text).

Conclusion:

This document is a formal FDA communication regarding a 510(k) clearance for a physical dental cement. It demonstrates substantial equivalence to existing predicate devices, focusing on composition and intended use rather than presenting performance data against specific acceptance criteria in the manner one would for a novel AI/SaMD.

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