Manufacturer registered with FDA
Crown Delta Corp.
Yorktown Hgts, NY, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 11 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 111976–2013
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1976–2026
Devices listed with FDA
What Crown Delta Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | VPS Silicone Adhesive | 2008 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Impression Material Syringe | 2010 |
| Resin ApplicatorKXR · Class 1 | — | Maker | ZerofloX | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Crown Delta Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 May 2013 | K122974 | TRYOUT-VPS HOLDING PASTE | EMA Dental Cement |
| 14 May 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW Impression Material |
| 7 Jan 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW Impression Material |
| 21 Jul 1987 | K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM | ELW Impression Material |
| 11 Jun 1987 | K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM | ELW Impression Material |
| 18 Oct 1984 | K843145 | TWO COMPONENT RTV VINYL SILICONE MATER | ELW Impression Material |
| 7 Jun 1982 | K821221 | DENTAL IMPRESSION MATERIAL | ELW Impression Material |
| 8 Jul 1980 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | ELW Impression Material |
| 31 Aug 1978 | K781083 | DENTAL SILICONE IMPRESSION MATERIAL | ELW Impression Material |
| 31 May 1978 | K780778 | RTV SILICONE HAND KNEADABLE PUTTY | ELW Impression Material |
| 21 Jul 1976 | K760231 | IMPRESSION MATERIAL, DENTAL SILICON RTV | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: Keystone Industries (3), Dharma Research, Inc. (1), Centrix, Inc. (1), Pac-Dent Inc. (1), 3D Dental Designs and Development LLC (1).
Also lists devices cleared under other names
Crown Delta Corp. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Silicon-Und Composite Spezialitaten GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Nov 1999 | K992001 | TRAY-LINK | Silicon-Und Composite Spezialitaten GmbH | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CROWN DELTA CORP.FDA reg. 2431069 | Yorktown, NY, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2431069). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.