Carrara Press System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K033667 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Disposable Screw Type Prophy Brush

  Class I

  FDA 510(k) K900507 Active Cleared 10 Apr 1990

• Sterile Flexofile Files and Instruments

  Class I

  FDA 510(k) K971606 Active Cleared 3 Jun 1997

• Delton F Pit & Fissure Sealant

  Class II

  FDA 510(k) K951296 Active Cleared 3 May 1995

• Fluoride Varnish

  Class II

  FDA 510(k) K031932 Active Cleared 15 Sep 2003

• Dentsply Cavitron Sps Scaler System

  Class II

  FDA 510(k) K970123 Active Cleared 11 Apr 1997

• Delton Fs Direct Delivery System

  Class II

  FDA 510(k) K982564 Active Cleared 6 Oct 1998

See all devices from Dentsply Intl. →

• What is the Carrara Press System used for?

  The Carrara Press System is designed for dental procedures to press porcelain materials. It is classified as a Powder, Porcelain device under product code EIH, intended for professional dental use.

• Is the Carrara Press System single-use or reusable?

  The device description does not specify whether the Carrara Press System is single-use or reusable. It is supplied as a system for dental procedures, but the manufacturer has not indicated its intended usage pattern regarding reuse.

• What regulatory approvals does the Carrara Press System have?

  The Carrara Press System received FDA 510(k) clearance on January 23, 2004, with decision code SESE indicating it was found substantially equivalent to predicate devices. It is classified under product code EIH with special controls.

• What components are included in the Carrara Press System?

  The Carrara Press System is supplied as a complete system for dental porcelain pressing procedures. However, the specific components included in the system are not detailed in the provided device information.