Clear Bite™ SPD1104

GUDID D813SPD11040

CLEARBITE CART SET MINT

DEN-MAT HOLDINGS, LLC

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material
Primary Device IDD813SPD11040
NIH Device Record Key9968e120-c3e5-43c7-a2a7-faf09749c374
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Bite™
Version Model NumberSPD1104
Catalog NumberSPD1104
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 Datefalse
Expiration Datetrue
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
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813SPD11040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

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

Devices Manufactured by DEN-MAT HOLDINGS, LLC

D8130398114010 - TENURE2024-05-16 TENURE MPB SYSTEM BAG
D8130398140000 - TENURE2024-05-16 TENURE 4G SAMPLE PACK
D813444000L0 - CCD BLUEWAVE LASER2023-10-18 CCD LASER WIRELESS LOANER
D8130561006970 - VAKT 2023-04-26 VAKT ALIGNER UPR & LWR
D8130303761050 - GBLOCK2023-03-14 GBLOCK DESENSITIZER 5ml
D8130303761100 - GBLOCK2023-03-14 GBLOCK DESENSITIZER 10ml
D8130562005300 - VAKT PRIVATE LABEL2023-03-14 VAKT ALIGNER UPPER
D8130562005350 - ORTHOCLEAR - PL VAKT2023-03-14 VAKT ALIGNER LOWER

Trademark Results [Clear Bite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEAR BITE
CLEAR BITE
77002533 not registered Dead/Abandoned
Remarkable Dental Products Inc.
2006-09-19

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