(77 days)
Pulpdent ENDODONTIC POST CEMENT KIT is a convenience package of dental materials used by the dentist to prepare the root canal and cement an endodontic post into the canal prior to core build up.
The kit contains one 4.5 gram syringe each of resin cement base and catalyst, one 10 ml bottle of bonding agent, 34 ml each of 17 % EDTA solution and 5.25 % sodium hypochlorite solution, plastic wells, mixing paper, mixing sticks and applicator tips.
This document, K962747, describes a Pulpdent Endodontic Post Cement Kit, which is a dental material and not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are standard for evaluating AI/ML medical devices, is not applicable in this context.
The document focuses on:
- Description and Intended Use: Explaining what the kit is and how it's used.
- Comparison with Predicate Products: Stating its substantial equivalence to previously approved devices.
- Safety and Effectiveness: Referencing general statements about dental restorative materials and specific components (EDTA and sodium hypochlorite) from established authorities like NIH and ADA. These are general statements about the categories of materials, not specific studies on this particular product demonstrating its performance against predefined acceptance criteria in a clinical setting.
Therefore, I cannot extract the requested information as it pertains to AI/ML powered medical devices.
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SEP 30 1988
EXHIBIT 7
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 FAX: (617) 926-6262
PULPDENT ENDODONTIC POST CEMENT KIT DEVICE NAME:
PREDICATE DEVICES:
Antical Contract
DESCRIPTION AND INTENDED USE:
Pulpdent ENDODONTIC POST CEMENT KIT is a convenience package of dental materials used by the dentist to prepare the root canal and cement an endodontic post into the canal prior to core build up. The kit contains one 4.5 gram syringe each of resin cement base and catalyst, one 10 ml bottle of bonding agent, 34 ml each of 17 % EDTA solution and 5.25 % sodium hypochlorite solution, plastic wells, mixing paper, mixing sticks and applicator tips.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent ENDODONTIC POST CEMENT KIT is substantially equivalent in composition and intended use as the 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... composites... 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.
The American Dental Association Council on Dental Therapeutics in their publication, Accepted Dental Therapeutics, considers both EDTA and sodium hypochlorite safe and effective aids in preparing a root canal for further procedures. Please see EXHIBIT 6 for the entire citations.
§ 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.