Inspire™ Esthetic Provisional Composite A2 152702

GUDID 00359883003944

Esthetic Provisional Composite

DEN-MAT HOLDINGS, LLC

Temporary dental crown/bridge resin
Primary Device ID00359883003944
NIH Device Record Key042ea7d2-51b0-444c-ab69-eccb3080c29f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInspire™ Esthetic Provisional Composite A2
Version Model Number152702
Catalog Number152702
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 Kittrue
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(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com

Device Dimensions

Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram
Weight71 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883003944 [Primary]

FDA Product Code

EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-20
Device Publish Date2025-03-12

Devices Manufactured by DEN-MAT HOLDINGS, LLC

00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack2025-03-26 Gingival Retraction Solution
00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit2025-03-26 Gingival Retraction Solution
00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack2025-03-24 VPS Impression Material
00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack2025-03-21 Wheel, Polishing Agent
00359883006501 - Clinician's Choice® G5 Sample Pack2025-03-21 Dental coating, tooth-desensitizing, professional
00359883000608 - PowerMix™ Automatic Impression Material Dispenser2025-03-20 Two-component dental material applicator, electric
00359883000615 - PowerMix™ Dynamic Mixing Tips2025-03-20 Dental material mixing nozzle, non-sterile
00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange2025-03-20 Device to engage the matrices and separate teeth

Trademark Results [Inspire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSPIRE
INSPIRE
98841259 not registered Live/Pending
The West Nottingham Academy in Cecil County
2024-11-07
INSPIRE
INSPIRE
98824841 not registered Live/Pending
Raus Coffee Company, LLC
2024-10-28
INSPIRE
INSPIRE
98751227 not registered Live/Pending
ENEWTON DESIGN LLC
2024-09-14
INSPIRE
INSPIRE
98732071 not registered Live/Pending
May, Megan Zugelder
2024-09-04
INSPIRE
INSPIRE
98732071 not registered Live/Pending
Lewis, Lisa
2024-09-04
INSPIRE
INSPIRE
98630185 not registered Live/Pending
KM Holding, LLC
2024-07-02
INSPIRE
INSPIRE
98407977 not registered Live/Pending
Sahara Group LLC
2024-02-16
INSPIRE
INSPIRE
98373585 not registered Live/Pending
STX SOFTWARE, LLC
2024-01-24
INSPIRE
INSPIRE
98223123 not registered Live/Pending
1426391 B.C. LTD.
2023-10-13
INSPIRE
INSPIRE
98074438 not registered Live/Pending
Megan Mae Beauty Products LLC
2023-07-07
INSPIRE
INSPIRE
98071172 not registered Live/Pending
Authentic Walk Creative Inc.
2023-07-05
INSPIRE
INSPIRE
98003183 not registered Live/Pending
TDC Development, Inc.
2023-05-18

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.