Crown Delta Corp.
Yorktown, NY, US
CROWN DELTA CORP. appears in FDA device records in Yorktown, NY. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Crown Delta Corp. between 1976 and 2013. The busiest year on record is 1978, with 4. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 4 |
| 1980 | 1 |
| 1982 | 1 |
| 1984 | 1 |
| 1987 | 2 |
| 1990 | 2 |
| 1993 | 1 |
| 1994 | 2 |
| 1996 | 1 |
| 2004 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122974 | TRYOUT-VPS HOLDING PASTE | EMA | Substantially Equivalent | |
| K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K955288 | HEARING AID IMPRESSION MATERIAL | ESD | Substantially Equivalent | |
| K940132 | PODIATRIC MATERIAL | MNE | Substantially Equivalent | |
| K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW | Substantially Equivalent | |
| K926150 | VINYL ADDITION SILICONE SYSTEM | ESD | Substantially Equivalent | |
| K901991 | SILICONE ELASTOMER PUTTY | MDA | Substantially Equivalent | |
| K901990 | VINYL SILICONE ELASTOMER MATERIAL | MDA | Substantially Equivalent | |
| K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM | ELW | Substantially Equivalent | |
| K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM | ELW | Substantially Equivalent | |
| K843145 | TWO COMPONENT RTV VINYL SILICONE MATER | ELW | Substantially Equivalent | |
| K821221 | DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K781907 | EAR STOPPLES FOR NOISE ATTENTION | EWD | Substantially Equivalent | |
| K781083 | DENTAL SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K780391 | PODIATRIC MATERIAL | MNE | Substantially Equivalent | |
| K780778 | RTV SILICONE HAND KNEADABLE PUTTY | ELW | Substantially Equivalent | |
| K760231 | IMPRESSION MATERIAL, DENTAL SILICON RTV | ELW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431069 | 2431069 | CROWN DELTA CORP. | 1520 FRONT ST., Yorktown, NY 10598 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
