FDA UDI
In Commercial Distribution
🇺🇸 United States
IBT Resin
DI: 00860002099347
·
Model: FLIBCL01
·
FORMLABS OHIO INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IBT Resin
- Primary DI
- 00860002099347
- Version / Model
- FLIBCL01
- Company Name
- FORMLABS OHIO INC.
- Labeler DUNS
- 106744280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-16
- Public Version
- 2
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 23e076d0-5b99-4013-bf4a-45bab07bd6cd
Device Description
IBT Resin is a light-curable polymer based material designed for 3D printing biocompatible, indirect bonding trays for dental bracket placement. Users should independently verify the suitability of the printed materials for their particular application and intended purpose. IBT Resin is a photopolymer resin made of a mixture of methacrylic esters and photoinitiators.
Device Characteristics
- Single Use
- No
- 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 | 10860002099344 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 00860002099347 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight