APEX Flex - Standard Pink

GUDID 00850070544597

SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850070544597
NIH Device Record Key66e13fed-8e28-4807-aef3-92cc2c1fd629
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX Flex - Standard Pink
Version Model NumberSRI-0202187
Company DUNS063005260
Company NameSprintray, 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 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
Phone800-914-8004
Emailsupport@sprintray.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SprintRay Apex Flex resin 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 *Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, SpecifyBetween 0 and 0 *The capsule must be kept sealed until the print is complete.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850070544597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

Devices Manufactured by Sprintray, Inc.

00850070544597 - APEX Flex - Standard Pink2025-07-29SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.
00850070544597 - APEX Flex - Standard Pink2025-07-29 SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentu
00850070544603 - APEX Flex - Light Pink2025-07-29 SprintRay APEX Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentu
00850070544412 - APEX Base - Light Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544429 - APEX Base - Original Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544436 - APEX Base - Dark Reddish Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544443 - APEX Base - Opaque Original Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544450 - OnX Tough 2 - A1 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850070544559 - OnX Tough 2 - A2 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp

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