Acupac® 4300-01-001

GUDID B7154300010010

Acupac® Medium

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 IDB7154300010010
NIH Device Record Keydbdc7e86-20a1-4360-adfd-6d8177e62379
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcupac®
Version Model Number4300-01-001
Catalog Number4300-01-001
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 Latextrue
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

Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound
Weight1 Pound

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [Primary]
HIBCCB7154300010010 [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 [Acupac®]

B7154420100Acupac® 30 Monomer
B715430007P0Acupac® 30 Natural
B715430006P0Acupac® Ethnic Dark
B715430003P0Acupac® Natural
B715430000P0Acupac® Light
B715412010P0Acupac® 30 Light
B715430001025P0Acupac® Medium
B715430002025P0Acupac® Characterized Medium
B715430002P0Acupac® Characterized Medium
B7154300020480Acupac® Characterized Medium
B7154300060480Acupac® Ethnic Dark
B7154300060010Acupac® Ethnic Dark
B7154300000010Acupac® Light
B7154300020010Acupac® Char Medium
B715412011P0Acupac® 30 Char Medium
B7154120110480Acupac® 30 Char Medium
B7154120110010Acupac® 30 Char Medium
B7154420000Acupac® 30 Monomer
B7154300030010Acupac® Natural
B7154300010010Acupac® Medium

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