The Hygenic Company, LLC
Akron, OH, US
THE HYGENIC COMPANY, LLC appears in FDA device records in Akron, OH. FDA records list 16 510(k) clearances between and , no PMA records and 2 registered establishments. 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 16 510(k) clearances for The Hygenic Company, LLC between 1979 and 1996. The busiest year on record is 1986, with 3. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 1 |
| 1990 | 3 |
| 1991 | 3 |
| 1993 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954990 | DENTAL DAM | EIE | Substantially Equivalent | |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | EAT | Substantially Equivalent | |
| K905418 | GATES GLIDDEN DRILLS | DZA | Substantially Equivalent | |
| K911225 | TRAY DOUGH | KGS | Substantially Equivalent | |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | EKS | Substantially Equivalent | |
| K900301 | NOVUS BONDING AGENT | EBI | Substantially Equivalent | |
| K900844 | WEDJETS | EIE | Substantially Equivalent | |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | KIF | Substantially Equivalent | |
| K881826 | ENDO-ICE | EAT | Substantially Equivalent for Some Indications | |
| K873644 | PULP PEN | EAT | Substantially Equivalent | |
| K863393 | ENDOCATER | LQY | Substantially Equivalent | |
| K854529 | INLAY WAX REGULAR | EGD | Substantially Equivalent | |
| K854530 | PREMIUM FLEXI-TOUGH | EGD | Substantially Equivalent | |
| K854527 | STICKY WAX | EGD | Substantially Equivalent | |
| K850863 | ULTRAFIL-LT (GUTTA PERCHA) | EKM | Substantially Equivalent | |
| K791970 | HYGENIC RUBBER DAM LUBRICANT | KMJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1519375 | 1519375 | THE HYGENIC COMPANY, LLC | 1245 HOME AVE., Akron, OH 44310 US | 2026 | and 11 more, listed in full below |
| 9681338 | 3003123739 | The Hygenic Corporation | Plot 6 Bemban Industrial Park, Batu Gajah Perak 31000 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KYRBag, Ice
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- ITGBandage, Cast
- FQMBandage, Elastic
- MDRBinder, Medical, Therapeutic
- IODComponents, Exercise
- EIEDam, Rubber
- DZADrill, Dental, Intraoral
- HRWDynamometer, Nonpowered
- IONExerciser, Non-Measuring
- EKSFile, Pulp Canal, Endodontic
- KQWGoniometer, Nonpowered
- EKMGutta-Percha
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- LQYLocator, Root Apex
- KMJLubricant, Patient
- LYGMassager, Therapeutic, Manual
- IQIOrthosis, Limb Brace
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- KGSRetention Device, Suture
- KOXSolvent, Adhesive Tape
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile
- KGXTape And Bandage, Adhesive
- EATTester, Pulp
- GAXTourniquet, Nonpneumatic
- EGDWax, Dental, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain