FDA UDI
In Commercial Distribution
🇺🇸 United States
Enamel Plus Temp ®
DI: EMICTEMP1N1
·
Model: TEMP1N
·
MICERIUM SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Enamel Plus Temp ®
- Primary DI
- EMICTEMP1N1
- Version / Model
- TEMP1N
- Catalog Number
- TEMP1N
- Company Name
- MICERIUM SPA
- Labeler DUNS
- 436661136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-02
- Public Version
- 1
- Public Version Date
- 2021-12-10
- Public Version Status
- New
- Public Device Record Key
- db908a51-b11c-440a-a2a1-9e826ce2cec9
Device Description
ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMP50BLUE, BLUE 50G POWDER - 1 TEMP50UD2, UD2 50g POWDER - 1 TEMP50UD3, UD3 50g POWDER - 1 TEMP50UD3,5 UD3.5 50g POWDER - 1 TEMP50UD4, UD4 50g POWDER - 1 TEMP50UE2, UE2 50g POWDER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 | EMICTEMP1N1 | 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