Medical Device Manufacturer · US , Mchenry , IL

Unitek Corp.

23 submissions · 23 cleared · Since 1980
23
Total
23
Cleared
0
Denied

Unitek Corp. — FDA 510(k) Submissions

Unitek Corp. has submitted 23 FDA 510(k) premarket notifications since 1980, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bracket, Metal, Orthodontic, Plier, Orthodontic, Alloy, Other Noble Metal, Bracket, Plastic, Orthodontic, Adhesive, Bracket And Tooth Conditioner, Resin . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286 · DYW Bracket, Plastic,... · Dental
Nov 1994 88d
ALASTIK
K933501 · EJF Bracket, Metal, Orthodontic · Dental
Apr 1994 283d
ALASTIK
K940165 · ECI Band, Elastic, Orthodontic · Dental
Mar 1994 60d
ALASTIK NS
K923999 · ECI Band, Elastic, Orthodontic · Dental
Jun 1993 318d
TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS
K924645 · JEX Plier, Orthodontic · Dental
Nov 1992 72d
DEBRACKETING INSTRUMENT
K924295 · JEX Plier, Orthodontic · Dental
Nov 1992 89d
GERMAN MINI DYNALOCK
K923432 · EJF Bracket, Metal, Orthodontic · Dental
Oct 1992 109d
ADHESIVE PRECOATED BRACKETS
K911271 · DYH Adhesive, Bracket And... · Dental
May 1991 68d
NONSTAINING ALASTIKS
K910288 · EJF Bracket, Metal, Orthodontic · Dental
Mar 1991 66d
ALASTIGARD
K890529 · EJF Bracket, Metal, Orthodontic · Dental
Mar 1989 35d
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · EBZ Activator, Ultraviolet,... · Dental
Apr 1988 69d
TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
K880393 · DYH Adhesive, Bracket And... · Dental
Mar 1988 62d
UNITEK CERAMIC BRACKET SYSTEM
K861965 · DYW Bracket, Plastic,... · Dental
Jun 1986 21d
UNITEK DISPOSABLE IMPRESSION SYRINGE
K851386 · EID Syringe, Restorative And... · Dental
Apr 1985 20d
UNITEK CONVERTIBLE CAP REMOVER TOOL
K843742 · JEX Plier, Orthodontic · Dental
Nov 1984 45d
HEATED GUTTA PERCHA DELIVERY SYSTEM
K832654 · EKM Gutta-percha · Dental
Sep 1983 49d
X-704
K832253 · EJS Alloy, Other Noble Metal · Dental
Aug 1983 51d
DOMINION
K831098 · EJT Alloy, Gold-based Noble... · Dental
Jun 1983 73d
STROMA II
K831096 · EJS Alloy, Other Noble Metal · Dental
Jun 1983 72d
CONCERTO
K831097 · EJS Alloy, Other Noble Metal · Dental
Jun 1983 72d
UNITEK PALATAL BAR
K812239 · DYT Maintainer, Space... · Dental
Sep 1981 41d
ROOT CANAL POST
K802515 · ELR Post, Root Canal · Dental
Nov 1980 28d
TONGUE HOLDER/SALIVA EJECTOR
K800210 · DYN Mouthpiece, Saliva Ejector · Dental
Feb 1980 5d
Filters
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