Etch Gel (12 grams) with 25 tips 93606

GUDID D876936060

Etch Gel is a high viscosity enamel etching agent used for bonding purposes. It represents a 33% solution of ortho-phosphoric acid, thickened with a combination of water soluble and water dispersible agents. Simple to wash out and clean. Tinted for application control. Includes 1 Etch Gel Syringe (12 grams) and 25 applicator tips.

ALMORE INTERNATIONAL INC

Dental etching solution
Primary Device IDD876936060
NIH Device Record Key4f2b2615-c2d2-4d14-ae9f-2aa87a997e91
Commercial Distribution StatusIn Commercial Distribution
Brand NameEtch Gel (12 grams) with 25 tips
Version Model Number93606
Catalog Number93606
Company DUNS009051723
Company NameALMORE INTERNATIONAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD876936060 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-15

Devices Manufactured by ALMORE INTERNATIONAL INC

D876936060 - Etch Gel (12 grams) with 25 tips 2019-11-25Etch Gel is a high viscosity enamel etching agent used for bonding purposes. It represents a 33% solution of ortho-phosphoric acid, thickened with a combination of water soluble and water dispersible agents. Simple to wash out and clean. Tinted for application control. Includes 1 Etch Gel Syringe (12 grams) and 25 applicator tips.
D876936060 - Etch Gel (12 grams) with 25 tips 2019-11-25 Etch Gel is a high viscosity enamel etching agent used for bonding purposes. It represents a 33% solution of ortho-phosphoric ac
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