Aqua-Prep F B-2824

GUDID D757B28240

Aqua-Prep F 30ml Bottle

BISCO INC.

Dental coating, tooth-desensitizing, professional
Primary Device IDD757B28240
NIH Device Record Key63c309f8-14af-49d9-8fa8-93a270776e31
Commercial Distribution StatusIn Commercial Distribution
Brand NameAqua-Prep F
Version Model NumberB-2824
Catalog NumberB-2824
Company DUNS053529939
Company NameBISCO 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757B28240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-06-03
Device Publish Date2017-06-12

On-Brand Devices [Aqua-Prep F]

D757B2824P1Aqua-Prep F 30ml Bottle Pkg
D757B28240Aqua-Prep F 30ml Bottle
D757B2822P1Aqua-Prep F 6ml Bottle Pkg
D757B28220Aqua-Prep F 6ml Bottle
00810111542517Aqua-Prep F 30ml Bottle Pkg
10810111542507Aqua-Prep F 6ml Bottle

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.