(46 days)
Elite H-D putties are thick, vinyl polysiloxane dental impression materials intended to be used in conjunction with more fluid vinyl polysiloxane impression materials in order to make dental impressions. The resulting impressions are used to make plaster models of the teeth.
Elite H-D Vinyl Polysiloxane Impression Materials - Putty Soft/Normal Setting & Fast Setting
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a dental impression material, establishing its substantial equivalence to a predicate device. It defines the intended use of the device but does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment for a performance study.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).