Fixtemp® C&B 4:1

• K Number: K241226
• Device Name: Fixtemp® C&B 4:1
• Manufacturer: Dreve Denatmid GmbH
• Date Cleared: 2024-05-31 ( 29 days)
• Product Code: EBG
• Regulation Number: 872.3770
• Type: Special
• Panel: DE
• Reference & Predicate Devices: K171729

Intended Use

Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.

Device Description

Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

Attribute	Acceptance Criteria (from predicate Fixtemp® C&B)	Reported Device Performance (Fixtemp® C&B 4:1)
Processing/Working Time	≥ 45 sec	≥ 45 sec
Curing Time in the mouth	≥ 2 - 3 min	≈ 2 - 3 min
Setting Time	≥ 6 min	≥ 6 min
Flexural Strength	> 60 MPa	> 60 MPa
Water Sorption	≤ 40 µg/mm³	≤ 40 µg/mm³
Duration	Short term

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.