Material, Impression

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2013-12-18TerminatedEmployee error

  3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.

  Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.

• 2013-02-13TerminatedPackaging process control

  Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

  Incorrect packaging of regular set and fast set cartridges.

• 2013-02-13TerminatedPackaging process control

  Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

  Incorrect packaging of regular set and fast set cartridges.

• 2012-11-08TerminatedNonconforming Material/Component

  The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

  The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.

• 2012-03-02TerminatedPackaging process control

  Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.

  Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.

• 2005-03-15TerminatedOther

  Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.

  Packaging defects could result in improper mixing ratios and unusable impressions.

• 2005-03-15TerminatedOther

  Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.

  Packaging defects could result in improper mixing ratios and unusable impressions.

• 2005-03-15TerminatedOther

  Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.

  Packaging defects could result in improper mixing ratios and unusable impressions.

• 2005-03-15TerminatedOther

  Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.

  Packaging defects could result in improper mixing ratios and unusable impressions.

• 2005-01-25TerminatedOther

  Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815

  The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.