Company ยท US
The Hygenic Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1996. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EAT | Tester, Pulp | 3 |
| EGD | Wax, Dental, Intraoral | 3 |
| EIE | Dam, Rubber | 2 |
| DZA | Drill, Dental, Intraoral | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| EKM | Gutta-Percha | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 |
| KGS | Retention Device, Suture | 1 |
| KIF | Resin, Root Canal Filling | 1 |
| KMJ | Lubricant, Patient | 1 |
| LQY | Locator, Root Apex | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 26, 1996 | K954990 | DENTAL DAM The Hygenic Corp. | EIE |
| May 27, 1993 | K930764 | ENDO-ICE-PULP TESTER-THERMAL The Hygenic Corp. | EAT |
| Jul 25, 1991 | K905418 | GATES GLIDDEN DRILLS The Hygenic Corp. | DZA |
| Apr 17, 1991 | K911225 | TRAY DOUGH The Hygenic Corp. | KGS |
| Mar 5, 1991 | K905640 | SOLID CORE GUTTA PERCHA CARRIER The Hygenic Corp. | EKS |
| May 15, 1990 | K900301 | NOVUS BONDING AGENT The Hygenic Corp. | EBI |
| Apr 16, 1990 | K900844 | WEDJETS The Hygenic Corp. | EIE |
| Jan 10, 1990 | K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) The Hygenic Corp. | KIF |
| Aug 23, 1988 | K881826 | ENDO-ICE The Hygenic Corp. | EAT |
| Oct 27, 1987 | K873644 | PULP PEN The Hygenic Corp. | EAT |
| Jun 11, 1987 | K863393 | ENDOCATER The Hygenic Corp. | LQY |
| Mar 10, 1986 | K854529 | INLAY WAX REGULAR The Hygenic Corp. | EGD |
| Mar 4, 1986 | K854530 | PREMIUM FLEXI-TOUGH The Hygenic Corp. | EGD |
| Mar 4, 1986 | K854527 | STICKY WAX The Hygenic Corp. | EGD |
| Apr 16, 1985 | K850863 | ULTRAFIL-LT (GUTTA PERCHA) The Hygenic Corp. | EKM |
| Nov 16, 1979 | K791970 | HYGENIC RUBBER DAM LUBRICANT The Hygenic Corp. | KMJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||