HI-I® 11028-006P

GUDID B71511028006P0

Special Fibered #1 "O-R" HI-I® Self Curing

FRICKE INTERNATIONAL, INC.

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured
Primary Device IDB71511028006P0
NIH Device Record Key503d4c3f-2555-48b9-af5d-b2ca932111c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHI-I®
Version Model Number11028-006P
Catalog Number11028-006P
Company DUNS957630726
Company NameFRICKE INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com
Phone630-540-1900
Emailcustomerservice@frickedental.com

Device Dimensions

Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound
Weight6 Pound

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]
HIBCCB71511028006P0 [Primary]

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing
EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [HI-I®]

B71507021006P0Special Fibered #1 HI-I®
B71507021001P0Special Fibered #1 HI-I®
B71513004025P0#200 Special Dark HI-I® Pour
B71513004006P0#200 Special Dark HI-I® Pour
B71513004001P0#200 Special Dark HI-I® Pour
B71507002025P0#200 Special Dark Short Fibered HI-I®
B715A56P0Associated #5 HI-I®
B715A525P0Associated #5 HI-I®
B715A49DP6P0Associated #49 DEEP HI-I®
B715A49DP1P0Associated #49 DEEP HI-I®
B715A16P0Associated #1 HI-I®
B715A125P0Associated #1 HI-I®
B715A12225P0Associated #122 HI-I®
B71525120006P0HI-JECT #1 "L" HI-I®
B715200300160P4 HI-I®
B71513145006P0Special Fibered #52 "H" HI-I® Pour
B71513145001P0Special Fibered #52 "H" HI-I® Pour
B71513088025P0Special Fibered #1 "L" "H" *HI-I* Pour
B71513058025P0Special Fibered #1 "A" HI-I® Pour
B71513058006P0Special Fibered #1 "A" HI-I® Pour
B71513049006P0Special Grain #6 HI-I® Pour
B71513049001P0Special Grain #6 HI-I® Pour
B71513041006P0Special Fibered #49 Deep HI-I® Pour
B71513041001P0Special Fibered #49 Deep HI-I® Pour
B71513038025P0Special Fibered #122 HI-I® Pour
B71513038006P0Special Fibered #122 HI-I® Pour
B71513030025P0Special Fibered #1 HI-I® Pour
B71513014600P0Special Fibered #1 "T" HI-I® Pour
B715130140480Special Fibered #1 "T" *HI-I* Pour
B71513014006P0Special Fibered #1 "T" HI-I® Pour
B71513014001P0Special Fibered #1 "T" HI-I® Pour
B71513011006P0#500 Light HI-I® Pour
B71513011001P0#500 Light HI-I® Pour
B71511044001P0Special Fibered #50 HI-I® Self Curing
B715110320480Special Fibered #1 HI-I SC
B71511032006P0Special Fibered #1 HI-I® SC
B71511032001P0Special Fibered #1 HI-I® SC
B71511012001P0Extra Fine HI-I® Self Curing
B71510010006P0#300 LIGHT *HI-I* LW
B71509050006P0LT HI-I® LW
B71509041006P0Special Fibered #50 HI-I® LW
B71509041001P0Special Fibered #50 HI-I® LW
B71509020006P0Special Fibered #1 HI-I® LW
B715070340480Special Fibered #1 "L-T" HI-I
B71507034025P0Special Fibered #1 "L-T" HI-I®
B71507034006P0Special Fibered #1 "L-T" HI-I®
B715070340060Special Fibered #1 "L-T" HI-I®
B71507034001P0Special Fibered #1 "L-T" HI-I®
B71507021025P0Special Fibered #1 HI-I
B71507004001P0#400 SPECIAL SF HI-I®

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