(98 days)
A BURL. CURING ADHESIVE CEMENT INTENDED FOR USE AS A LUTING MATERIAL FOR BONDING INLAYS, ONLAYS, CROWNS, BRIDGES, LAMINATE VENEERS ETC. TO POSTERLY PERFARED TEETH. ALSO INDICATED AS AN AGENT FOR AFFECTING REPAIRS OF TOOTH . COLORED VENEED VENEERS BUNDED TO ATT ECTING READING FOR FREGOUS OR PRECIOUS . FOR THE LATTER, THE KIT CONTAINS A NOBLE METAL PRIMING MATERIAL WHICH SIGNIFICANTLY INCREASES THE BONS STRENGTH OF THE REPAIR. THE KIT ALSO CONTAINS A PORCELAIN PRIMER OF THE IS RECORITIENDED FOR WE IN REBAIRING FRACTURED DENTAL PORCECAINS. IT MEDIATES AN ADHESINE BOND BETWEEN THE PORCECAIN SUBSCRIPTE AND AN OVERLIANG COMPOSITE PESIN.
Parkell's TOTALBOND is a dual-curing adhesive cement intended for use as a luting material for bonding inlays, onlays, crowns, and bridges to properly prepared teeth. It is also indicated for use as an agent for affecting repairs of tooth-colored veneers bonded to dental alloys, either non-precious or precious. For the latter instance, the supplied kit contains a noble metal-Priming material which significantly increases the bond strength of the repair. The kit also contains a porcelain-primer that is recommended for use in repairing fractured dental porcelains. It mediates an adhesive bond between the porcelain substrate and an overlying composite resin.
This document is a 510(k) summary for a dental adhesive resin cement called "TOTALBOND." The information provided does not contain details about acceptance criteria or a study proving that the device meets such criteria. Instead, it is a regulatory document outlining the submission for market clearance, the intended use of the device, and the FDA's decision regarding its substantial equivalence to previously marketed devices.
Therefore, I cannot provide the requested information as it is not present in the given text.
The provided text focuses on the administrative and regulatory aspects of the device's submission, such as:
- Submitter and Contact Information: Parkell Products Inc. and Nelson J. Gendusa, DDS.
- Submission Date: February 3, 1999.
- Trade Name and Common Name: TOTALBOND, Adhesive Resin Cement.
- Classification: Class II, Product Code EMA.
- Description/Intended Use: Dual-curing adhesive cement for bonding dental restorations (inlays, onlays, crowns, bridges, laminate veneers) and for repairing tooth-colored veneers and fractured dental porcelains.
- FDA Communication: A letter from the FDA stating that the device is substantially equivalent to predicate devices and can be marketed.
- Indications for Use: Reiterates the intended uses for bonding and repair.
To answer your questions, I would need a different type of document, such as a detailed study report, a clinical trial summary, or a sections of the 510(k) submission that specifically address performance testing and acceptance criteria.
§ 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.