Medical Device Manufacturer · US , Mchenry , IL

The Hygenic Corp.

16 submissions · 15 cleared · Since 1979
16
Total
15
Cleared
0
Denied

The Hygenic Corp. — FDA 510(k) Submissions

The Hygenic Corp. has submitted 16 FDA 510(k) premarket notifications since 1979, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wax, Dental, Intraoral, Tester, Pulp, Dam, Rubber, Resin, Root Canal Filling, Resin, Denture, Relining, Repairing, Rebasing . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
DENTAL DAM
K954990 · EIE Dam, Rubber · Dental
Jan 1996 87d
ENDO-ICE-PULP TESTER-THERMAL
K930764 · EAT Tester, Pulp · Dental
May 1993 104d
GATES GLIDDEN DRILLS
K905418 · DZA Drill, Dental, Intraoral · Dental
Jul 1991 233d
TRAY DOUGH
K911225 · KGS Retention Device, Suture · General & Plastic Surgery
Apr 1991 27d
SOLID CORE GUTTA PERCHA CARRIER
K905640 · EKS File, Pulp Canal, Endodontic · Dental
Mar 1991 78d
NOVUS BONDING AGENT
K900301 · EBI Resin, Denture, Relining,... · Dental
May 1990 113d
WEDJETS
K900844 · EIE Dam, Rubber · Dental
Apr 1990 53d
DENTAL ENDODONTIC CEMENT (MODIFICATION)
K894092 · KIF Resin, Root Canal Filling · Dental
Jan 1990 216d
ENDO-ICE
K881826 · EAT Tester, Pulp · Dental
Aug 1988 116d
PULP PEN
K873644 · EAT Tester, Pulp · Dental
Oct 1987 48d
ENDOCATER
K863393 · LQY Locator, Root Apex · Dental
Jun 1987 281d
INLAY WAX REGULAR
K854529 · EGD Wax, Dental, Intraoral · Dental
Mar 1986 117d
STICKY WAX
K854527 · EGD Wax, Dental, Intraoral · Dental
Mar 1986 111d
PREMIUM FLEXI-TOUGH
K854530 · EGD Wax, Dental, Intraoral · Dental
Mar 1986 111d
ULTRAFIL-LT (GUTTA PERCHA)
K850863 · EKM Gutta-percha · Dental
Apr 1985 46d
HYGENIC RUBBER DAM LUBRICANT
K791970 · KMJ Lubricant, Patient · General Hospital
Nov 1979 45d
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