FDA UDI
In Commercial Distribution
🇺🇸 United States
SprintRay Apex Base - Original Pink - 1 Kg
DI: 00850039704666
·
Model: SRI-0202154
·
Sprintray, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SprintRay Apex Base - Original Pink - 1 Kg
- Primary DI
- 00850039704666
- Version / Model
- SRI-0202154
- Company Name
- Sprintray, Inc.
- Labeler DUNS
- 063005260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-16
- Public Version
- 2
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 84dfdbc9-e67a-4199-a8c8-cffdd3577bc0
Device Description
APEX Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
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 | 00850039704666 | GS1 |
Customer Contacts
- Phone
- 800-914-8004
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221678 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Kilogram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material