Material, Impression
Regulation 872.3660
3510(k)s in 12 months (404 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in ELW
| Company | 510(k)s | Recalls |
|---|---|---|
| Heraeus Kulzer, Inc. | 21 | 4 |
| Zhermack S.P.A. | 19 | 0 |
| Dentsply Intl. | 18 | 0 |
| Cavex Holland BV | 16 | 0 |
| GC America, Inc. | 15 | 0 |
| Harry J. Bosworth Co. | 10 | 1 |
| Sybron Dental Specialties | 10 | 1 |
| Zhermack Dental Production | 11 | 0 |
| Crown Delta Corp. | 10 | 0 |
| Espe Dental AG | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2022 | Clinician's Choice Dental Products Inc. Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure.
Product ID: 013912 Terminated |
ELW | K053014 |
| Nov 9, 2016 | Ivoclar Vivadent, Inc. Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY --
Product Usage:
Dental impression material Terminated |
ELW | K083739 |
| Nov 9, 2016 | Ivoclar Vivadent, Inc. Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY --
Product Usage:
Dental impression material Terminated |
ELW | K083739 |
| Nov 9, 2016 | Ivoclar Vivadent, Inc. Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY --
product Usage:
Dental impression material Terminated |
ELW | K083739 |
| Dec 18, 2013 | 3M Company - Health Care Business 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.
Impres Terminated |
ELW | K000591 |
| Feb 13, 2013 | Ultradent Products, Inc. Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics. Terminated |
ELW | K972027 |
| Feb 13, 2013 | Ultradent Products, Inc. Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. Terminated |
ELW | K972027 |
| Nov 8, 2012 | Kerr Corporation The brand name of the device is AlgiNot, a dental impression material.
Product Part Numbers
AlgiNot Intra Kit 34683
AlgiNot Volume Refill Terminated |
ELW | K050604 |
| Mar 2, 2012 | Sybron Dental Specialties Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. Terminated |
ELW | K914178 |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582. Terminated |
ELW | K030318 |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584. Terminated |
ELW | K030318 |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583. Terminated |
ELW | K030318 |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. Terminated |
ELW | K030318 |
| Jan 25, 2005 | Harry J Bosworth Company 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 Terminated |
ELW | None listed |
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