FDA UDI
In Commercial Distribution
🇺🇸 United States
APEX Flex - Light Pink
DI: 00850070544603
·
Model: SRI-0202188
·
Sprintray, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APEX Flex - Light Pink
- Primary DI
- 00850070544603
- Version / Model
- SRI-0202188
- Company Name
- Sprintray, Inc.
- Labeler DUNS
- 063005260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-21
- Public Version
- 1
- Public Version Date
- 2025-07-29
- Public Version Status
- New
- Public Device Record Key
- 4e679789-bb5f-4407-a3d2-be5f915b26c2
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850070544603 | GS1 |
Customer Contacts
- Phone
- 800-914-8004
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250617 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store SprintRay Apex Flex resin at 15-25oC (60-77oF) and avoid direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use SprintRay Apex Flex resin after the expiration date printed on the bottle
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep the bottle closed and/or the tank lid securely attached when not in use
- Type
- Special Storage Condition, Specify
- Special Conditions
- Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
- Type
- Special Storage Condition, Specify
- Special Conditions
- The capsule must be kept sealed until the print is complete.