DuraFinish™ S295

GUDID 00810000525188

DuraFinish™ Composite Glaze

PARKELL, INC.

Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating
Primary Device ID00810000525188
NIH Device Record Keyf00152ae-9c3c-4f89-a5ae-51127c11371c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraFinish™
Version Model NumberS295
Catalog NumberS295
Company DUNS009900424
Company NamePARKELL, 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

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 6 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not store in refrigerator; store at room temperature. Storage at low temperatures may cause phase separation.
Storage Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000525188 [Primary]

FDA Product Code

EBDCoating, Filling Material, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-20
Device Publish Date2018-10-26

On-Brand Devices [DuraFinish™]

00810000525195All-Cure DuraFinish™ Composite Glaze
00810000525188DuraFinish™ Composite Glaze
M595S2960All-Cure DuraFinish™ Composite Glaze
M595S2950DuraFinish™ Composite Glaze

Trademark Results [DuraFinish]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURAFINISH
DURAFINISH
88205069 5793198 Live/Registered
Popular Bath Products Inc
2018-11-26
DURAFINISH
DURAFINISH
86168634 4694409 Live/Registered
Cold Spring Granite Company
2014-01-17
DURAFINISH
DURAFINISH
86000726 4988992 Live/Registered
Owens Corning Intellectual Capital, LLC
2013-07-02
DURAFINISH
DURAFINISH
85788993 not registered Dead/Abandoned
GlassCraft Door I Limited Partnership
2012-11-28
DURAFINISH
DURAFINISH
85699666 4960507 Live/Registered
Maytag Properties, LLC
2012-08-09
DURAFINISH
DURAFINISH
85169217 4206643 Dead/Cancelled
Atlas Lighting Products, Inc.
2010-11-04
DURAFINISH
DURAFINISH
78590357 not registered Dead/Abandoned
Coatings Specialist Group (CSG)
2005-03-18

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