Crown - C2

GUDID 00850039704840

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 ID00850039704840
NIH Device Record Key7e277aea-179b-457d-a7dd-fd8879174485
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrown - C2
Version Model NumberSRI-0202182
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
GS100850039704840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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

Devices Manufactured by Sprintray, Inc.

00850039704925 - OnX Tough 2 Bleach Single-unit Capsule2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850039704932 - OnX Tough 2 Bleach Single-unit Capsule 3-Pack2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850039704949 - OnX Tough 2 A1 Single-unit Capsule2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850039704956 - OnX Tough 2 A1 Single-unit Capsule 3-Pack2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850039704918 - SprintRay Retainer2024-10-25 SprintRay Retainer is an alternative to traditional thermoplastic material used for the fabrication of retainers. It is intended
00850039704741 - Ceramic Crown - A1 - Single-unit Capsule 1-Pack2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im
00850039704758 - Ceramic Crown - A2 - Single-unit Capsule 1-Pack2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im
00850039704765 - Ceramic Crown - B1 - Single-unit Capsule 1-Pack2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.