FDA UDI
In Commercial Distribution
🇺🇸 United States
Enamel Plus Temp ®
DI: EMICTEMPUD31
·
Model: TEMPUD3
·
MICERIUM SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enamel Plus Temp ®
- Primary DI
- EMICTEMPUD31
- Version / Model
- TEMPUD3
- Catalog Number
- TEMPUD3
- Company Name
- MICERIUM SPA
- Labeler DUNS
- 436661136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-06
- Public Version
- 1
- Public Version Date
- 2024-08-14
- Public Version Status
- New
- Public Device Record Key
- 26b88c35-1b70-4478-a713-86bfd521d240
Device Description
Enamel Plus Temp UD3, 100g
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 63591 | Dental acrylic resin | A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EMICTEMPUD31 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103474 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 400 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 3 – 30 Degrees Celsius