ProTech UBAR UBAR11F

GUDID D814UBAR11F0

ProTech UBAR 100 ml Monomer

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

Primary Device ID	D814UBAR11F0
NIH Device Record Key	4c3e0474-ee9e-4805-aecd-215fabbdeac1
Commercial Distribution Status	In Commercial Distribution
Brand Name	ProTech UBAR
Version Model Number	UBAR11F
Catalog Number	UBAR11F
Company DUNS	117374900
Company Name	PROTECH PROFESSIONAL PRODUCTS INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D814UBAR11F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131036

FDA Product Code

EBI	Resin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-05-28
Device Publish Date	2019-05-20

On-Brand Devices [ProTech UBAR]

D814RUCVPG1	ProTech UBAR Value Pack 80 gram polymer shades: JP, 1069LO, 1060LL, 506RR, Clear
D814RUCV11GL1	ProTech UBAR polymer 160 gram shade clear
D814RUCV11GD1	ProTech UBAR polymer 160 gram shade 506RR
D814RUCV11GC1	ProTech UBAR polymer 160 gram shade 1060LL
D814RUCV11GA1	ProTech UBAR polymer 160 gram shade 1069LO
D814RUCV11G1	ProTech UBAR polymer 160 gram shade JP
D814RUCV11F1	ProTech UBAR 200 ml monomer
D814RUCV11E1	ProTech UBAR 14 ml bonding liner
D814RUCV11AL1	ProTech UBAR Value Kit Shade Clear - 160 gram powder, 200 ml monomer and 14 ml bonding liner
D814RUCV11AD1	ProTech UBAR Kit Shade 506RR - 160 gram powder, 200 ml monomer and 14 ml bonding liner
D814RUCV11AC1	ProTech UBAR Value Kit Shade 1060LL - 160 gram powder, 100 ml monomer and 14 ml bonding liner
D814RUCV11AA1	ProTech UBAR Value Kit Shade 1069LO - 160 gram powder, 200 ml monomer and 14 ml bonding liner
D814RUCV11A1	ProTech UBAR Value kit shade JP - 160 gram powder, 200 ml monomer and 14 ml bonding liner
D814RUC11GL1	ProTech UBAR 80 gram polymer shade clear
D814RUC11GD1	ProTech UBAR 80 gram polymer shade 506RR
D814RUC11GC1	ProTech UBAR 80 gram polymer shade 1060LL
D814RUC11GA1	ProTech UBAR polymer 80 gram shade 1069LO
D814RUC11G1	ProTech UBAR polymer 80 gram shade JP
D814RUC11F1	ProTech UBAR 100 ml monomer
D814RUC11E1	ProTech UBAR 7 ml bonding liner
D814RUC11AL1	ProTech UBAR kit shade clear - 80 gram powder, 100 ml monomer and 7 ml bonding liner
D814RUC11AD1	ProTech UBAR kit shade 506RR - 80 gram powder, 100 ml monomer and 7 ml bonding liner
D814RUC11AC1	ProTech UBAR kit shade 1060LL - 80 gram powder, 100 ml monomer and 7 ml bonding liner
D814RUC11AA1	ProTech UBAR Kit shade 1069LO - 80 gram powder, 100 ml monomer and 7 ml bonding liner
D814RUC11A1	ProTech UBAR Kit shade JP - 80 gram powder, 100 ml monomer and 7 ml bonding liner
D814UBARV11GL0	ProTech UBAR Powder Only 160 g Shade Clear
D814UBARV11GA0	ProTech UBAR Powder Only 160 g Shade 1069LO
D814UBARV11G0	ProTech UBAR 160g Powder Only Shade JP
D814UBARV11F0	ProTech UBAR 200 ml Monomer
D814UBARV11AL0	ProTech UBAR Value Kit Shade Clear - 160 g Powder, 200 ml Monomer, 14 ml Bonding Liner
D814UBARV11AA0	ProTech UBAR Value Kit Shade 1069LO - 160 g Powder, 200 ml Monomer, 14 ml Bonding Liner
D814UBARV11A0	ProTech Plus UBAR Value Kit Shade JP - 160 g Powder, 200 ml Monomer, 14 ml Bonding Liner
D814UBAR11GL0	ProTech UBAR 80 g Powder Only Shade Clear
D814UBAR11GA0	ProTech UBAR Powder Only 80 g Shade 1069LO
D814UBAR11G0	ProTech UBAR 80g Powder Only Shade JP
D814UBAR11F0	ProTech UBAR 100 ml Monomer
D814UBAR11AL0	ProTech UBAR Kit Shade Clear - 80 g Powder, 100 ml Monomer, 7 ml Bonding Liner
D814UBAR11AA0	ProTech UBAR Kit Shade 1069LO - 80 g Powder, 100 ml Monomer, 7 ml Bonding Liner
D814UBAR11A0	ProTech UBAR Kit Shade JP - 80 g Powder, 100 ml Monomer, 7 ml Bonding Liner
D814UBAR11GD0	ProTech UBAR 80 g Powder Only Shade 506RR
D814UBAR11GC0	ProTech UBAR 80 g Powder Only Shade 1060LL
D814UBAR11AD0	ProTech UBAR Kit Shade 506RR - 80 g Powder, 100 ml Monomer, 7 ml Bonding Liner
D814UBAR11AC0	ProTech UBAR Kit Shade 1060LL - 80 g Powder, 100 ml Monomer, 7 ml Bonding Liner
D814UBARV11GD0	ProTech UBAR Powder Shade 506RR 160 g
D814UBARV11AD0	UBAR Value Kit Shade 506RR - 160 gram powder, 200 ml monomer, 14 ml bonding liner
D814UBARTAVP0	25 g ProTech UBAR Tooth Acrylic Variety Pack - Shades 59,62,65,81,87
D814UBAR87C0	440 g ProTech UBAR Tooth Acrylic Powder Shade 87
D814UBAR87B0	110 g ProTech UBAR Tooth Acrylic Powder Shade 87
D814UBAR87A0	50 g ProTech UBAR Tooth Acrylic Powder Shade 87
D814UBAR870	25 g ProTech UBAR Tooth Acrylic Powder Shade 87