FDA UDI
In Commercial Distribution
🇺🇸 United States
TEMP TABS
DI: D0331430330
·
Model: 143033
·
DMG AMERICA, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TEMP TABS
- Primary DI
- D0331430330
- Version / Model
- 143033
- Company Name
- DMG AMERICA, LLC
- Labeler DUNS
- 106792427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-18
- Public Version
- 1
- Public Version Date
- 2025-04-28
- Public Version Status
- New
- Public Device Record Key
- f780cf90-0edf-4a4c-9f0c-b3529479297d
Device Description
FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34799 | Composite dental impression material | A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0331430330 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033227 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 145 Degrees Fahrenheit