← Product Code [EMA](/productcode/EMA) · K962747

# PULPDENT ENDODONTIC POST CEMENT KIT (K962747)

_Pulpdent Corp. · EMA · Sep 30, 1996 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962747

## Device Facts

- **Applicant:** Pulpdent Corp.
- **Product Code:** [EMA](/productcode/EMA.md)
- **Decision Date:** Sep 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for 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.

## Device Story

Convenience kit for endodontic post cementation; contains resin cement (base/catalyst), bonding agent, 17% EDTA solution, 5.25% sodium hypochlorite solution, and accessories (wells, mixing paper, sticks, tips). Used by dentists in clinical settings to prepare root canal surfaces and secure posts. EDTA and sodium hypochlorite facilitate canal preparation; resin cement/bonding agent provide adhesion for post placement. Supports core build-up procedures.

## Clinical Evidence

No clinical data; safety based on historical usage of dental restorative materials and literature citations regarding EDTA and sodium hypochlorite efficacy in root canal preparation.

## Technological Characteristics

Kit components: resin cement (base/catalyst), bonding agent, 17% EDTA solution, 5.25% sodium hypochlorite solution. Accessories: plastic wells, mixing paper, mixing sticks, applicator tips. Chemical-based dental materials.

## Regulatory 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. 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.

## Submission Summary (Full Text)

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53

SEP 30 1996 K962747

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

DEVICE NAME: PULPDENT ENDODONTIC POST CEMENT KIT

PREDICATE DEVICES:

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.

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**Source:** [https://fda-staging.innolitics.com/device/K962747](https://fda-staging.innolitics.com/device/K962747)

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