TEMP BOND CLEAR

• K Number: K972844
• Device Name: TEMP BOND CLEAR
• Manufacturer: KERR DENTAL MATERIALS CENTER
• Date Cleared: 1997-10-03 ( 63 days)
• Product Code: EMA
• Regulation Number: 872.3275
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.

Device Description

Kerr's Temp Bond Clear is designed to fulfill all of the requirements of a successful temporary restorative cementation material. These requirements are itemized below.

1. Ease of placement. Kerr Temp Bond Clear handles very similarly to the ZOE cements alresdy familiar to dentists.
2. Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,
3. Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.
4. Strength. The glass reinforced resin resists mastication forces that would fracture a ZOE type cement.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for Kerr Temp Bond Clear Temporary Cement:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "efficacy" as "suitability to the intended purpose," which is demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices. The acceptance criteria are implicitly set by the performance of predicate devices already on the market (Temp Bond ZOE in this case), with the goal of performing "as well or better."

Acceptance Criteria (Implicit, based on Predicate Device Performance)	Reported Device Performance (Temp Bond Clear)
Diametral Tensile Strength @ 24 hr.	4285 psi (Better than Temp Bond ZOE)
Water Solubility	0.5 % (Better than Temp Bond ZOE)
Film Thickness

Regulation Number and Section

§ 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.