FDA UDI
In Commercial Distribution
🇺🇸 United States
DentaTOOTH
DI: 09359215000109
·
Model: 03624
·
ASIGA PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DentaTOOTH
- Primary DI
- 09359215000109
- Version / Model
- 03624
- Company Name
- ASIGA PTY LTD
- Labeler DUNS
- 745954045
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-12
- Public Version
- 1
- Public Version Date
- 2025-05-20
- Public Version Status
- New
- Public Device Record Key
- 2036026f-925d-414b-b314-b419fab6dcd2
Device Description
DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce temproary dental restorations. DentaTOOTH has been validated for use with the Asiga Max and Pro Series printers for manufacture of temporary dental resins at 385nm wavelengths.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 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 | 09359215000109 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243370 | 000 |