NightGuard Flex SRI-0202015
GUDID 10850039704069
Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. 3D scanned image of a patient's teeh
Sprintray, Inc.
Dental appliance fabrication material, resin| Primary Device ID | 10850039704069 |
| NIH Device Record Key | 687dbe7a-e4fb-4e63-93ad-c33349b0dd2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NightGuard Flex |
| Version Model Number | SRI-0202015 |
| Catalog Number | SRI-0202015 |
| Company DUNS | 063005260 |
| Company Name | Sprintray, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com |
Device Dimensions
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
| Total Volume | 1 Liter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location. Do not store in an oxygen-free environment. Avoid freezing the material. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850039704062 [Primary] |
| GS1 | 10850039704069 [Package] Contains: 00850039704062 Package: Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212448
FDA Product Code
| KMY | Positioner, Tooth, Preformed |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-08 |
| Device Publish Date | 2022-02-28 |
Devices Manufactured by Sprintray, Inc.
| 00850039704925 - OnX Tough 2 Bleach Single-unit Capsule | 2024-12-17 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-Pack | 2024-12-17 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 Capsule | 2024-12-17 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-Pack | 2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp |
| 00850039704918 - SprintRay Retainer | 2024-10-25 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-Pack | 2024-09-17 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-Pack | 2024-09-17 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-Pack | 2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im |
Trademark Results [NightGuard Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIGHTGUARD FLEX 90805150 not registered Live/Pending |
SprintRay Inc 2021-06-30 |
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