Material, Impression
Dental · 21 CFR 872.3660
Recent MDR events
369 adverse event reports on file
- SMILESETJul 16, 2026InjuryOrtho Dental Lab, Llc3032193293-2026-00003
- NEOCOLLOID LL BUSTA 500 G.Jun 10, 2026MalfunctionZhermack S.p.a.9614794-2026-00001
- 3M¿ PARADIGM¿ REGULAR BODY FAST SET VPS IMPRESSION MATERIALSep 30, 2025Injury3m Espe Dental Products3005174370-2025-00002
- AVA GEL REFILL 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00012
- JELTRATE REG DUSTLESS 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00013
- AVA GEL REFILL 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00014
- AVA GEL REFILL 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00015
- AVA GEL REFILL 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00016
- AVA GEL REFILL 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00017
- AVA GEL REFILL 410 GRSep 3, 2025InjuryDentsply Industria E Comercio Ltda8040288-2025-00018
Event type breakdown
Recalls
14 recall events for this product code
- 3M Company - Health Care BusinessTerminatedDec 18, 2013
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce th
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.
Z-0535-2014 · View FDA record ↗ - Ultradent Products, Inc.TerminatedFeb 13, 2013
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.
Z-0811-2013 · View FDA record ↗ - Ultradent Products, Inc.TerminatedFeb 13, 2013
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.
Z-0812-2013 · View FDA record ↗ - Kerr CorporationTerminatedNov 8, 2012
The brand name of the device is AlgiNot, a dental impression material.
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.
Z-0268-2013 · View FDA record ↗ - Sybron Dental SpecialtiesTerminatedMar 2, 2012
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.
Z-1146-2012 · View FDA record ↗ - Heraeus Kulzer Inc.TerminatedMar 15, 2005
Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.
Packaging defects could result in improper mixing ratios and unusable impressions.
Z-0624-05 · View FDA record ↗ - Heraeus Kulzer Inc.TerminatedMar 15, 2005
Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.
Packaging defects could result in improper mixing ratios and unusable impressions.
Z-0625-05 · View FDA record ↗ - Heraeus Kulzer Inc.TerminatedMar 15, 2005
Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.
Packaging defects could result in improper mixing ratios and unusable impressions.
Z-0626-05 · View FDA record ↗ - Heraeus Kulzer Inc.TerminatedMar 15, 2005
Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.
Packaging defects could result in improper mixing ratios and unusable impressions.
Z-0627-05 · View FDA record ↗ - Harry J Bosworth CompanyTerminatedJan 25, 2005
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 - W
The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
Z-0421-05 · View FDA record ↗
Registered firms
648 firms currently registered for this product code
Titanlinks Logistics Llc
Newark, DE, US
Oketz Logistics Llc
Coral Gables, FL, US
Seilglobal Co., Ltd
Busan Gyeongnam, KR
Mainline Medical Dental Supply
North York Ontario, CA
Solventum Germany Gmbh
SEEFELD Bavaria, DE
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Gc Corporation-fuji Oyama Factory
SUNTO-GUN, Shizuoka-Ken, JP
Samtrade Supplies Inc.
TORONTO Ontario, CA
Kettenbach Gmbh & Co Kg
ESCHENBURG Hesse, DE
Dylan Lucas International Inc
Vaughan Ontario, CA
Hygedent Inc.
Beijing, CN
Lld Care D.o.o.
Zagreb Zagreb, Grad, HR
Pac-dent Inc.
Brea, CA, US
Gc Corp.
ITABASHI-KU Tokyo, JP
Zapalign Llc
Fort Lauderdale, FL, US
Prismatik Dentalcraft, Inc.
Irvine, CA, US
510(k) clearances
402 clearances for this product code
- DiaDent Group InternationalMar 19, 2026
K254112 · Dia-X Sil Bite
- Vigodent Indústria E Comercio LtdaOct 31, 2025
K253501 · Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
- Dent4you AGJun 27, 2025
K250969 · JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
- Beijing Okvd Biological Technology , Ltd.Dec 27, 2024
K241924 · Elastic Impression Material
- Dent4you AGNov 15, 2024
K242360 · Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
- B&E Korea Co., Ltd.Feb 13, 2024
K233954 · Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
- Innovative Product Brands, Inc.Apr 27, 2023
K223892 · DentMix VPS Impression Material
- No Stress Impress, LLCJan 19, 2023
K213175 · No Stress Impress