Reveal HD Bulk H-9334A2

GUDID 50810111542611

Reveal HD Bulk A2 50ct Unit Dose (0.25g ea)

BISCO INC.

Dental composite resin
Primary Device ID50810111542611
NIH Device Record Key865b86d3-a71e-4a7b-9c3d-2d9c2406e676
Commercial Distribution StatusIn Commercial Distribution
Brand NameReveal HD Bulk
Version Model NumberH-9334A2
Catalog NumberH-9334A2
Company DUNS053529939
Company NameBISCO INC.
Device Count50
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 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
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
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
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
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
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
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111542616 [Unit of Use]
GS140810111542614 [Primary]
GS150810111542611 [Package]
Contains: 40810111542614
Package: Item No: H-9334A2P [1 Units]
In Commercial Distribution
HIBCCD757H9334A20 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-11-11
Device Publish Date2022-11-03

On-Brand Devices [Reveal HD Bulk]

D757H933B10Reveal HD Bulk B1 Unit Dose (0.25g)
D757H933A30Reveal HD Bulk A3 Unit Dose (0.25g)
D757H933A20Reveal HD Bulk A2 Unit Dose (0.25g)
D757H933A10Reveal HD Bulk A1 Unit Dose (0.25g)
D757H9334B1P0Reveal HD Bulk B1 50ct Unit Dose (0.25g ea) Pkg
D757H9334B10Reveal HD Bulk B1 50ct Unit Dose (0.25g ea)
D757H9334A3P1Reveal HD Bulk A3 50ct Unit Dose (0.25g ea) Pkg
D757H9334A30Reveal HD Bulk A3 50ct Unit Dose (0.25g ea)
D757H9334A2P1Reveal HD Bulk A2 50ct Unit Dose (0.25g ea) Pkg
D757H9334A20Reveal HD Bulk A2 50ct Unit Dose (0.25g ea)
D757H9334A1P1Reveal HD Bulk A1 50ct Unit Dose (0.25g ea) Pkg
D757H9334A10Reveal HD Bulk A1 50ct Unit Dose (0.25g ea)
D757H9332B1P1Reveal HD Bulk B1 25ct Unit Dose (0.25g ea) Pkg
D757H9332B10Reveal HD Bulk B1 25ct Unit Dose (0.25g ea)
D757H9332A3P1Reveal HD Bulk A3 25ct Unit Dose (0.25g ea) Pkg
D757H9332A30Reveal HD Bulk A3 25ct Unit Dose (0.25g ea)
D757H9332A2P1Reveal HD Bulk A2 25ct Unit Dose (0.25g ea) Pkg
D757H9332A20Reveal HD Bulk A2 25ct Unit Dose (0.25g)
D757H9332A1P1Reveal HD Bulk A1 25ct Unit Dose (0.25g ea) Pkg
D757H9332A10Reveal HD Bulk A1 25ct Unit Dose (0.25g ea)
D757H9330A2PS1Reveal HD Bulk A2 3ct Unit Dose Pkg
D757H931B1P1Reveal HD Bulk B1 3g Syringe Pkg
D757H931B10Reveal HD Bulk B1 3g Syringe
D757H931A3P1Reveal HD Bulk A3 3g Syringe Pkg
D757H931A30Reveal HD Bulk A3 3g Syringe
D757H931A2P1Reveal HD Bulk A2 3g Syringe Pkg
D757H931A20Reveal HD Bulk A2 3g Syringe
D757H931A1P1Reveal HD Bulk A1 3g Syringe Pkg
D757H931A10Reveal HD Bulk A1 3g Syringe
10810111542569Reveal HD Bulk A1 3g Syringe
30810111542617Reveal HD Bulk A2 25ct Unit Dose (0.25g)
20810111542634Reveal HD Bulk B1 25ct Unit Dose (0.25g ea)
20810111542627Reveal HD Bulk A3 25ct Unit Dose (0.25g ea)
10810111542590Reveal HD Bulk B1 3g Syringe
20810111542603Reveal HD Bulk A1 25ct Unit Dose (0.25g ea)
10810111542583Reveal HD Bulk A3 3g Syringe
10810111542576Reveal HD Bulk A2 3g Syringe
50810111542611Reveal HD Bulk A2 50ct Unit Dose (0.25g ea)
40810111542607Reveal HD Bulk A1 50ct Unit Dose (0.25g ea)
40810111542638Reveal HD Bulk B1 50ct Unit Dose (0.25g ea)

Trademark Results [Reveal HD Bulk]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVEAL HD BULK
REVEAL HD BULK
87812373 5615054 Live/Registered
Bisco, Inc.
2018-02-27

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