SprintRay Nightguard Flex 2 - Ocean Blue - 1 Kg

GUDID 00850039704635

SprintRay NightGuard Flex 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850039704635
NIH Device Record Key69b2c90a-131b-4ae7-a180-4f3f5f3c0e7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay Nightguard Flex 2 - Ocean Blue - 1 Kg
Version Model NumberSRI-0202146
Company DUNS063005260
Company NameSprintray, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com

Device Dimensions

Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.
Special Storage Condition, SpecifyBetween 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
Special Storage Condition, SpecifyBetween 0 and 0 *Before disposal, completely polymerize.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704635 [Primary]

FDA Product Code

KMYPositioner, Tooth, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-01
Device Publish Date2024-03-22

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