Dry-Bond 030755000

GUDID D8130307550000

DRY-BOND 10mL W/INST

DEN-MAT HOLDINGS, LLC

Orthodontic bracket adhesive
Primary Device IDD8130307550000
NIH Device Record Key90190783-bae6-48be-9977-d54055e38232
Commercial Distribution StatusIn Commercial Distribution
Brand NameDry-Bond
Version Model Number030755000
Catalog Number030755000
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to source of ignition or open flame
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130307550000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZPSolution, Cement Disolving

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Dry-Bond]

D81375500DRY-BOND 25mL
D81375250COMP SOLVENT/SURFACE COND 25mL
D81375000DRY-BOND 240mL
D8130307550000DRY-BOND 10mL W/INST

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