Crown - D3

GUDID 00850039704857

SprintRay Crown is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work. The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50um print layer thickness, and light energy of 28.8 mW/cm2. It is available in the following shades: Bleach, A1, A2, A3, B1, C2, D2, B3, D3. The expected duration of use is based on in vitro testing where abrasion volume up to 6 mm3 and height loss up to 1.2 mm were observed under the test conditions (i.e. loading up to 2.4 MC).

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850039704857
NIH Device Record Key69aa9581-b7bf-4a3a-a311-406c620acdfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrown - D3
Version Model NumberSRI-0202184
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
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com

Device Dimensions

Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram
Weight250 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *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 *Store Crown 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 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704857 [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 Date2024-08-27
Device Publish Date2024-08-19

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