(61 days)
For use as a dental cement in various applications, including luting, repair of fractured bridge resins, cementation of adhesive bridge prostheses and CR core posts.
The product is a dental cement which can be either light cured or self cured.
The provided text is a 510(k) Pre-Market Notification for a dental cement (Bistite II DC). It outlines the intended use, safety information, and substantial equivalence to other marketed devices. However, the document does not contain the results of a study demonstrating that the device meets specific acceptance criteria.
The 510(k) summary (Exhibit D) and the FDA's response letter (Pages 1 & 2) primarily focus on:
- Device Description: What the device is (a dental cement), its intended use (luting, repair of fractured bridges, etc.), and user (dental practitioners).
- Substantial Equivalence: Listing predicate devices to which Bistite II DC is claimed to be substantially equivalent (Bistite II SC, Panavia 21, C&B Metabond).
- Safety Information: Contraindications and precautions.
- Regulatory Classification: The FDA confirms the device's classification (Class II, Product Code EMA, Regulation Number 872.3275).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment because this data is not present in the provided text.
To answer your request, a document detailing performance testing, clinical studies, or engineering bench testing with defined acceptance criteria and their outcomes would be necessary.
§ 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.