FDA UDI
In Commercial Distribution
🇺🇸 United States
IBT Flex Resin
DI: 00860002099361
·
Model: FLIBFL01
·
FORMLABS OHIO INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IBT Flex Resin
- Primary DI
- 00860002099361
- Version / Model
- FLIBFL01
- Catalog Number
- FLIBFL01
- Company Name
- FORMLABS OHIO INC.
- Labeler DUNS
- 106744280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-08
- Public Version
- 1
- Public Version Date
- 2023-11-16
- Public Version Status
- New
- Public Device Record Key
- f9fe73d7-bbb0-49ea-8d69-47cc44adad79
Device Description
IBT Flex Resin is a light-curable polymer based material designed for 3D printing biocompatible, indirect bonding trays for dental bracket placement. IBT Flex Resin is a photopolymer resin made of a mixture of methacrylic esters and photoinitiators.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 10886000209936 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 00860002099361 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight